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https://staging.previsionpolicy.com/right-to-try-clears-senate-modified-bill-assures-drugs-are-under-fda-purview-more-work-for-fda-not-more-control 2017-08-09 weekly 0.9 https://staging.previsionpolicy.com/pfizer-s-xeljanz-psoriatic-arthritis-fda-approval-likely-adcomm-questions-proposed-claim-on-radiographic-progression 2017-08-09 weekly 0.9 https://staging.previsionpolicy.com/weekly-highlights-july-31-august-4 2017-08-09 weekly 0.9 https://staging.previsionpolicy.com/fda-shows-interest-in-drug-development-for-c3g-rare-kidney-disease-trial-design-issues-highlighted-at-external-pfdd-meeting 2017-08-22 weekly 0.9 https://staging.previsionpolicy.com/fdara-clears-senate-with-right-to-try-on-separate-track-clean-user-fee-bill-still-adds-to-fda-to-do-list 2017-08-09 weekly 0.9 https://staging.previsionpolicy.com/cder-office-of-regulatory-affairs-prepare-to-meet-user-fee-inspection-goals-with-new-concept-of-operations 2017-08-22 weekly 0.9 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https://staging.previsionpolicy.com/oce-highlights-importance-of-supportive-data-early-inclusion-of-patients-in-trials-at-cns-metastases-product-development-workshop 2019-03-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-tirf-rems-requirements-strengthened-more-actions-may-be-coming 2019-03-28 weekly 0.9 https://staging.previsionpolicy.com/senate-aging-drug-pricing-proposals-include-improving-transparency-setting-out-of-pocket-caps-hearing-witnesses-have-tough-words-for-pharma 2019-06-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-implements-bba-change-on-medicaid-rebates-for-line-extensions-score-lowered 2019-03-29 weekly 0.9 https://staging.previsionpolicy.com/pfizer-looking-at-dashboard-updates-on-clinical-trial-progress-for-patients-as-one-way-to-start-data-sharing 2019-03-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-gop-senator-proposes-international-retail-list-price-index-bill 2019-04-01 weekly 0.9 https://staging.previsionpolicy.com/oncology-trial-eligibility-guidances-evidence-in-adults-should-trigger-pediatric-patient-inclusion-criteria-outlined-for-five-under-studied-populations 2019-04-02 weekly 0.9 https://staging.previsionpolicy.com/hhs-finalizes-dtc-price-disclosure-rule-impact-on-ads-and-prices-highly-uncertain-but-industry-now-agrees-the-list-price-matters 2019-05-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-opioid-dose-limits-role-of-higher-doses-will-be-advisory-committee-topic-june-11-12 2019-04-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-creates-pay-for-delay-among-drug-pricing-bills-slated-for-markup-by-full-house-e-c-committee-on-april-3 2019-04-02 weekly 0.9 https://staging.previsionpolicy.com/antimicrobial-drugs-panel-endorses-fda-approach-to-mabs-for-rabies-development-program-with-reservations-about-recruitment 2019-04-26 weekly 0.9 https://staging.previsionpolicy.com/gene-therapy-durability-challenges-for-long-term-safety-and-outcomes-assessments-posed-by-highly-effective-one-time-treatments 2019-04-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-abbvie-wins-washington-state-hep-c-netflix-like-bid 2019-04-30 weekly 0.9 https://staging.previsionpolicy.com/interchangeable-insulin-fda-public-meeting-continues-rhetorical-push-but-underscores-slow-moving-path-with-biosimilar-transition 2019-04-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medpac-exec-director-mathews-will-testify-at-medicare-b-and-d-drug-pricing-hearing 2019-04-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-workshop-for-adenoviral-infection-drug-development 2019-05-01 weekly 0.9 https://staging.previsionpolicy.com/creates-pay-for-delay-and-sham-citizen-petition-bills-pass-house-judiciary-committee-ftc-study-on-pbm-practices-rides-along-with-drug-pricing-package 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0.9 https://staging.previsionpolicy.com/fda-oncology-expanded-access-program-project-facilitate-will-launch-later-in-may-agency-will-track-requests-reasons-for-denial 2019-05-17 weekly 0.9 https://staging.previsionpolicy.com/fda-panel-narrowly-recommends-approval-of-chiesi-s-bronchitol-for-cf-despite-modest-benefit-negative-pulmonary-exacerbation-trend 2019-05-09 weekly 0.9 https://staging.previsionpolicy.com/bacitracin-iv-likely-to-be-withdrawn-in-unusual-case-following-overwhelming-vote-by-fda-panel-on-negative-risk-benefit-profile 2019-05-02 weekly 0.9 https://staging.previsionpolicy.com/from-gap-discount-to-cap-discount-medpac-proposal-for-new-part-d-design-to-lower-specialty-prices 2019-04-08 weekly 0.9 https://staging.previsionpolicy.com/cber-using-claims-ehr-database-as-precursor-to-reviews-in-osteoarthritis-sickle-cell-diabetes-shows-how-sentinel-can-aid-new-product-review 2019-04-08 weekly 0.9 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https://staging.previsionpolicy.com/fda-clear-message-on-first-covid-19-vaccine-is-necessary-to-win-over-public-surveys-suggest-importance-for-agency-to-steer-clear-from-politics 2020-07-07 weekly 0.9 https://staging.previsionpolicy.com/manufacturing-amid-covid-19-fda-urges-contingency-plans-for-gmp-compliance-in-new-guidance 2020-06-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-remdesivir-inhaled-version-to-enter-phase-i-trials-this-week 2020-06-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-bioavailability-bioequivalence-sample-compliance-guidance-forwarded-to-omb 2020-06-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-oncology-center-of-excellence-unveils-project-patient-voice-with-treatment-symptom-frequency-chart 2020-06-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hr3-drug-pricing-provisions-part-of-democratic-election-strategy-bill 2020-06-25 weekly 0.9 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2021-10-27 weekly 0.9 https://staging.previsionpolicy.com/mandatory-prescriber-education-for-opioids-after-all-fda-exploring-upgraded-rems-but-urged-to-go-beyond-making-existing-program-a-requirement 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biopharma-congress-virtual-series-acting-fda-commissioner-woodcock-oce-director-pazdur-cms-jon-blum 2021-10-28 weekly 0.9 https://staging.previsionpolicy.com/democratic-drug-price-negotiation-modifications-would-further-incentivize-biologic-product-development-versus-small-molecules 2021-11-02 weekly 0.9 https://staging.previsionpolicy.com/fda-inspectional-backlog-flagged-as-possible-impediment-to-bsufa-iii-commitments-during-feedback-meeting 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pfizer-biontech-s-covid-vaccine-for-5-11-year-olds-cdc-presentations-on-myocarditis-unprecedented-surveillance-effort 2021-11-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-tougher-than-hr3-democrats-drug-pricing-bill-has-no-floor-price-in-negotiation 2021-11-04 weekly 0.9 https://staging.previsionpolicy.com/acting-fda-commissioner-woodcock-tries-to-address-mckinsey-purdue-opioid-concerns-at-senate-help-hearing-but-with-little-success 2021-11-04 weekly 0.9 https://staging.previsionpolicy.com/levo-therapeutics-needs-another-trial-for-prader-willi-syndrome-treatment-carbetocin-fda-advisory-committee-says-confirms-negative-fda-review 2021-11-04 weekly 0.9 https://staging.previsionpolicy.com/icer-panel-wants-bristol-s-mavacamten-price-at-about-15-000-urges-patients-to-press-sponsor-ahead-of-hypertrophic-cardiomyopathy-launch 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/democratic-pricing-plan-leaves-launch-prices-in-manufacturers-hands-but-negotiation-may-be-tougher-than-hr3 2022-04-04 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-senate-pandemic-response-bill-includes-directives-for-fda-on-decentralized-trials-foreign-inspections-and-rwe 2022-01-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biogen-eisai-give-details-on-aduhelm-confirmatory-study-racial-diversity-is-key-goal 2022-01-27 weekly 0.9 https://staging.previsionpolicy.com/fda-white-house-interactions-may-improve-with-cder-deputy-sipes-joining-office-of-science-technology-jungman-to-be-policy-lead-in-cder 2022-01-27 weekly 0.9 https://staging.previsionpolicy.com/senate-covid-response-bill-includes-fda-reforms-platform-approvals-revived-directives-on-rwe-foreign-inspections-de-centralized-trials-are-part-of-discussion-draft 2022-05-19 weekly 0.9 https://staging.previsionpolicy.com/niemann-pick-coa-measure-needs-bolstering-but-still-holds-deep-value-in-type-c-research-npc-community-tells-fda-duke-endpoint-meeting 2022-01-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-user-fee-reauthorization-kick-off-hearing-set-for-feb-3-pharmaceutical-programs 2022-01-28 weekly 0.9 https://staging.previsionpolicy.com/keytruda-takes-top-spot-in-medicare-part-b-drug-spending-with-2020-now-released-biosimilars-covid-have-impact-on-top-10-list 2022-01-28 weekly 0.9 https://staging.previsionpolicy.com/part-d-hits-milestone-majority-of-rx-beneficiaries-are-enrolled-in-medicare-advantage-plans-medpac-says-policy-to-streamline-plan-choices-appears-to-be-working 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/complex-innovative-trial-design-case-studies-posted-by-fda-three-examples-in-pilot-project-include-lilly-pain-amgen-lupus-and-roche-lymphoma 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/rmat-expedited-designation-showing-appeal-to-aav-gene-therapy-development-projects-grounding-in-clinical-benefit-and-range-of-post-market-alternatives-appear-well-suited 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/part-d-point-of-sale-pricing-rule-would-save-manufacturers-almost-15-billion-over-10-years-cms-starts-with-pharmacy-payments-to-lower-beneficiary-costs-not-rebates 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/340b-payment-cuts-in-medicare-part-b-supreme-court-oral-arguments-run-against-hhs-key-question-may-be-how-much-discretion-hhs-will-lose 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/oncology-center-of-excellence-2-0-change-in-fda-leadership-may-present-opportunity-to-grant-full-review-authority-to-oce 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-could-device-user-fees-hold-up-pdufa-vii-congressional-health-leaders-send-letter-to-fda 2022-01-31 weekly 0.9 https://staging.previsionpolicy.com/fda-orange-book-report-shows-lack-of-consensus-on-changes-rems-related-and-digital-patents-are-focus-area-for-new-ideas 2022-01-31 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-arpa-h-house-hearing-will-go-on-despite-resignation-of-biden-chief-science-advisor-eric-lander 2022-02-08 weekly 0.9 https://staging.previsionpolicy.com/antibody-drug-conjugate-complexity-and-narrow-therapeutic-window-addressed-in-fda-draft-guidance-on-pharmacology-considerations 2022-02-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-non-opioid-acute-pain-guidance-includes-discussion-of-opioid-sparing-effects 2022-02-09 weekly 0.9 https://staging.previsionpolicy.com/arpa-h-real-world-preview-house-hearing-addresses-how-development-agency-would-fit-among-established-groups 2022-02-09 weekly 0.9 https://staging.previsionpolicy.com/fda-acute-pain-drug-development-guidance-outlines-three-opioid-sparing-claims-but-sets-high-bar-for-each-general-advice-unchanged-from-2014-draft-but-novel-mechanisms-may-need-more 2022-02-09 weekly 0.9 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https://staging.previsionpolicy.com/pfdd/spinal-muscular-atrophy 2022-03-11 weekly 0.9 https://staging.previsionpolicy.com/fda-mandatory-recall-authority-passes-house-as-part-of-competes-act-along-with-100-million-to-fund-advanced-manufacturing-centers-will-it-survive-senate-conference 2022-02-14 weekly 0.9 https://staging.previsionpolicy.com/humira-biosimilar-competition-heads-aam-medicare-objectives-clearing-inspection-backlog-also-priority-for-generics-biosimilars-industry 2022-02-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-nominee-robert-califf-set-to-clear-senate 2022-02-15 weekly 0.9 https://staging.previsionpolicy.com/rwe-guidance-on-regulatory-decision-making-fda-stresses-clarity-on-role-of-evidence-in-development-program-fit-for-purpose-data 2022-02-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-amylyx-als-treatment-amx0035-headed-to-fda-advisory-committee-march-30 2022-02-16 weekly 0.9 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https://staging.previsionpolicy.com/gene-editing-draft-guidance-fda-recommends-staggered-enrollment-with-children-last-clinically-meaningful-primary-endpoint-a-requirement 2022-03-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-continues-to-meet-hiring-goals 2022-03-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-covid-vaccine-efficacy-guidance-could-be-tested-with-moderna-eua-request-for-children-under-six 2022-03-23 weekly 0.9 https://staging.previsionpolicy.com/cber-emergency-ind-expanded-access-requests-return-to-baseline-after-2020-spike-still-show-clear-upward-trend-over-past-decade 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-quality-metric-reporting-fda-solicits-comment-on-plan-to-proceed 2022-03-08 weekly 0.9 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0.9 https://staging.previsionpolicy.com/supreme-court-likely-to-rule-against-hhs-on-340b-payment-cuts-broad-agency-deference-to-stay-intact-legal-experts-say-at-brookings-event 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/fda-accelerated-approval-reforms-included-in-budget-proposal-confirmatory-trial-plan-feasibility-test-needed-for-approval-withdrawal-procedures-simpler 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/fda-hiring-process-and-results-continue-to-improve-external-assessment-indicates-but-more-coordination-needed 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/amyloidosis-public-private-partnership-with-fda-working-on-multi-domain-endpoints-federated-data-analytics-approach 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/fda-sintilimab-review-completes-public-re-set-on-china-only-trials-lilly-innovent-orient-11-is-positive-study-agency-says-but-inadequate-for-us-approval-of-pd1-inhibitor 2022-04-04 weekly 0.9 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https://staging.previsionpolicy.com/covid-vaccine-sponsors-should-demonstrate-super-superiority-of-variant-vaccines-to-primary-doses-fda-says-in-revised-guidance 2022-03-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-insulin-co-pay-cap-passes-the-house-one-year-delay-in-rebate-rule 2022-04-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-nci-leadership-change-coming-amid-moonshot-reboot-and-while-nih-director-search-continues 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/fda-tech-data-modernization-efforts-helped-in-pandemic-inspection-response-covid-fostered-rwd-research-lab 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/cms-guidance-asks-manufacturers-to-make-it-easy-for-states-to-join-value-based-pricing-agreements-add-gnups-to-list-of-medicaid-acronyms-to-know 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/fda-s-gene-therapies-advisory-committee-bluebird-bio-reviews-could-mark-start-of-more-product-reviews-ahead-for-cber-panel 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/amylyx-amx0035-for-als-likely-headed-for-fda-rejection-after-agency-wins-close-no-vote-in-tough-context 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/amylyx-amx0035-for-als-fda-unpersuaded-by-current-dataset-including-overall-survival-data-committee-will-be-asked-to-back-agency-versus-strong-patient-support 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/cber-plans-to-finalize-neurodegenerative-gene-therapy-guidance-in-2022-developing-voluntary-consensus-standards-recognition-program-for-regenerative-medicine 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/gene-therapy-dosing-caps-not-recommended-by-fda-advisory-committee-but-standards-urged-to-address-empty-capsids-and-potential-toxicity 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/acip-readies-for-covid-vaccine-boosters-policy-framework-suggests-same-priority-order-as-original-doses-once-fda-signs-off 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/genentech-tecentriq-accelerated-approval-should-be-maintained-for-triple-negative-breast-cancer-fda-committee-says-after-glitch-filled-meeting 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/j-j-covid-19-single-shot-vaccine-authorized-by-fda-ongoing-two-dose-study-lower-efficacy-in-older-age-group-with-comorbidities-are-issues-to-watch 2022-04-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-covid-funding-bill-dedicates-5-billion-to-therapeutics 2022-04-05 weekly 0.9 https://staging.previsionpolicy.com/user-fee-reauthorization-kick-off-in-senate-dems-push-drug-pricing-generic-biosimilar-topics-in-opening-hearing-not-accelerated-approval-reforms 2022-04-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pfizer-expects-submission-of-three-dose-pediatric-covid-vaccine-eua-request-for-children-under-in-june-5 2022-05-03 weekly 0.9 https://staging.previsionpolicy.com/multi-component-biomarkers-framework-discussion-begins-fda-wants-to-know-how-biomarkers-are-developed-not-just-how-they-perform 2022-04-05 weekly 0.9 https://staging.previsionpolicy.com/fda-liquid-biopsy-draft-guidance-describes-potential-for-ctdna-as-early-endpoint-if-meta-analyses-can-address-outstanding-issues 2022-05-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-novartis-accelerated-approval-of-alpelisib-for-novel-pros-indication-based-on-rwe 2022-04-06 weekly 0.9 https://staging.previsionpolicy.com/cber-exploring-intermediate-pathways-for-some-cell-therapies-house-user-fee-bill-has-one-starting-point 2022-05-12 weekly 0.9 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https://staging.previsionpolicy.com/fda-quality-management-maturity-white-paper-program-will-benefit-regulatory-flexibility-for-postapproval-changes-advisory-committee-planned-this-year 2022-04-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-project-frontrunner-targeting-earlier-cancer-settings-for-accelerated-approval 2022-04-07 weekly 0.9 https://staging.previsionpolicy.com/fda-s-covid-19-vaccine-priority-is-another-booster-dose-this-fall-advisory-committee-leans-toward-switch-to-multi-valent-product 2022-04-07 weekly 0.9 https://staging.previsionpolicy.com/part-d-price-inflation-is-real-medpac-data-indicate-in-first-review-of-rebate-data-part-b-prices-are-immediate-focus-with-recommendations-a-year-away 2022-04-07 weekly 0.9 https://staging.previsionpolicy.com/cms-sticks-to-its-guns-on-aduhelm-and-accelerated-approval-all-beta-amyloid-alzheimer-s-therapies-face-ced-although-full-approvals-have-easier-path 2022-04-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-finalizes-updated-ich-guidance-on-clinical-trials-e8 2022-04-08 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-u2-odac-review-highlights-april-agenda-another-milestone-in-oncology-accelerated-approval-and-safety-projects 2022-04-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-workshop-on-antimicrobials-for-uncomplicated-uti-june-3 2022-04-11 weekly 0.9 https://staging.previsionpolicy.com/fda-suggests-enhancements-to-opioid-prescriber-education-blueprint-while-debate-over-mandates-flexibility-continues 2022-04-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-aduhelm-sets-no-new-direction-cms-national-coverage-decisions-for-drugs-will-remain-rare-situation 2022-04-13 weekly 0.9 https://staging.previsionpolicy.com/fda-wants-diversity-plan-from-all-ind-holders-by-end-of-phase-ii-meeting-and-preferably-earlier-oncology-project-equity-leads-to-fda-wide-guidance 2022-04-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-fda-user-fee-bill-heads-to-full-committee-may-18-cures-hiring-authority-will-be-expanded 2022-05-17 weekly 0.9 https://staging.previsionpolicy.com/moving-beyond-aduhelm-fda-cms-parallel-conversation-on-post-market-data-is-critical-cell-gene-therapy-is-poster-child-for-what-comes-next 2022-04-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-finalizes-bioavailability-study-guidance 2022-04-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-tg-therapeutics-withdraws-ukoniq-pending-u2-bla-ahead-of-odac-meeting 2022-04-15 weekly 0.9 https://staging.previsionpolicy.com/pi3k-inhibitor-class-provides-backdrop-for-fda-oncology-office-to-push-dose-optimization-pre-odac-journal-article-outlines-issues-tg-pulls-bla 2022-04-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-oncology-dose-optimization-likely-to-be-key-focus-of-scaled-back-odac 2022-04-18 weekly 0.9 https://staging.previsionpolicy.com/fda-gene-therapy-advisory-committee-adds-two-virologists-terms-extended-to-create-core-of-six-members-through-2026 2022-04-18 weekly 0.9 https://staging.previsionpolicy.com/advance-purchase-agreements-may-be-left-to-emergency-settings-sponsors-tell-icer-they-don-t-see-de-risking-r-d-as-attractive-outside-of-covid-response 2022-04-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-commissioner-califf-to-testify-on-fda-budget-april-27 2022-04-19 weekly 0.9 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https://staging.previsionpolicy.com/fda-s-case-for-dose-optimization-in-oncology-slow-down-in-phase-i-speed-up-overall-development-will-sponsors-buy-it 2022-05-04 weekly 0.9 https://staging.previsionpolicy.com/fda-advisory-committee-updating-coming-in-2023-califf-says-senior-agency-leaders-detail-top-line-priorities-on-aa-user-fees-and-importation 2022-05-04 weekly 0.9 https://staging.previsionpolicy.com/alzheimer-s-pipeline-is-robust-cder-s-cavazzoni-says-during-user-fee-hearing-too-soon-to-speculate-on-impact-of-cms-aduhelm-decision 2022-05-04 weekly 0.9 https://staging.previsionpolicy.com/fda-prepares-for-multi-cancer-screening-regulatory-reviews-device-center-has-experience-with-rwd-oce-interested-in-impact-on-drug-trials 2022-04-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-foreign-inspections-still-no-clarity-on-return-to-normal 2022-04-26 weekly 0.9 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https://staging.previsionpolicy.com/arpa-h-will-need-early-communication-with-fda-to-bring-discoveries-through-development-woodcock-says-workload-capacity-will-be-issue 2022-05-17 weekly 0.9 https://staging.previsionpolicy.com/complex-generics-at-fda-covid-impact-felt-across-the-board-from-inspections-to-fewer-anda-filings 2022-05-17 weekly 0.9 https://staging.previsionpolicy.com/pediatric-study-waivers-in-oncology-fda-developing-framework-to-consider-requests-odac-supports-flexible-approach-in-crowded-classes 2022-05-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-appropriations-fda-budget-hearing-rescheduled-for-may-19 2022-05-13 weekly 0.9 https://staging.previsionpolicy.com/senate-fda-user-fee-bill-has-limited-drug-biologic-reforms-but-ambitious-changes-to-ldt-cosmetic-and-supplement-authorities 2022-05-17 weekly 0.9 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weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-s-califf-in-crisis-management-mode-infant-formula-shortage 2022-05-25 weekly 0.9 https://staging.previsionpolicy.com/fda-s-vaccines-advisory-committee-unanimously-recommends-authorization-of-pfizer-moderna-covid-vaccines-in-young-children-agency-will-turn-attention-to-strain-composition-for-2022-2023 2022-07-11 weekly 0.9 https://staging.previsionpolicy.com/rx-import-q-a-guidance-reiterates-plan-parameters-outlined-in-final-rule-fda-showing-step-forward-without-opening-border 2022-05-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-arpa-h-staffing-begins-with-ex-darpa-program-manager-adam-russell 2022-05-26 weekly 0.9 https://staging.previsionpolicy.com/fda-quality-management-maturity-initiative-aims-to-be-proactive-and-rewarding-for-sponsors-encourage-more-punish-less-is-opq-theme 2022-05-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-novavax-covid-vaccine-eua-request-set-for-june-7-advisory-committee-review 2022-05-27 weekly 0.9 https://staging.previsionpolicy.com/cder-cber-are-aligned-on-arc-rare-disease-initiative-surrogate-endpoint-biomarker-work-should-start-early-agency-officials-say-at-fda-duke-margolis-workshop 2022-05-27 weekly 0.9 https://staging.previsionpolicy.com/bluebird-beti-cel-takes-fda-back-to-gene-therapy-replacements-for-current-treatments-thalassemia-vote-means-bluebird-has-two-blas-to-finish-over-summer 2022-06-20 weekly 0.9 https://staging.previsionpolicy.com/senate-user-fee-bill-directs-fda-to-set-up-internal-accelerated-approval-council-other-aa-provisions-largely-harmonize-with-house-approach 2022-05-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-drug-pricing-bubbling-back-up-as-manchin-schumer-talks-get-more-serious 2022-05-31 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-makena-aa-withdrawal-hearing-questions-include-final-vote-on-whether-drug-should-remain-available-while-appropriate 2022-06-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-labeling-webpages-for-industry-include-patient-labeling-resources-for-prescription-drugs 2022-06-06 weekly 0.9 https://staging.previsionpolicy.com/fda-after-covid-cder-s-key-learnings-remain-de-centralized-trials-remote-inspections-and-supply-chain-oversight-eua-transition-appears-manageable-on-new-drug-side 2022-06-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-expected-to-pass-fda-user-fee-reauthorization-bill-today 2022-06-07 weekly 0.9 https://staging.previsionpolicy.com/cder-workplace-culture-is-focus-of-retention-efforts-after-covid-re-vamped-equal-voice-process-is-one-step 2022-06-07 weekly 0.9 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https://staging.previsionpolicy.com/fda-enterprise-modernization-needs-more-funding-to-move-past-pilot-stage-inspections-are-early-focus-of-woodcock-s-priority-project 2022-08-05 weekly 0.9 https://staging.previsionpolicy.com/niemann-pick-advocates-push-for-regulatory-flexibility-but-fda-stands-firm-on-need-for-placebo-controls 2022-08-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-drug-pricing-reform-clears-the-senate-modest-changes 2022-08-08 weekly 0.9 https://staging.previsionpolicy.com/drug-price-reform-bill-heads-to-house-final-passage-likely-august-12-senate-tweaks-reduce-inflation-penalty-impact-but-not-fundamental-pricing-dynamics 2022-08-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-rule-on-medicaid-rebate-misclassification-is-pending-at-omb 2022-08-09 weekly 0.9 https://staging.previsionpolicy.com/drug-price-negotiations-threaten-stepwise-development-strategy-lilly-ceo-ricks-says-shorter-lifecycles-force-larger-first-launches 2022-08-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-atara-tab-cel-bla-may-be-possible-without-additional-clinical-trial 2022-08-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-infant-formula-shortage-filling-fda-commissioner-califf-s-calendar 2022-08-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-democrats-will-attempt-to-pass-the-inflation-reduction-act-and-related-drug-pricing-reforms-aug-12 2022-08-12 weekly 0.9 https://staging.previsionpolicy.com/regulatory-approvals-with-more-uncertainty-should-be-considered-in-pandemic-related-therapeutic-development-national-academy-of-medicine-report-says 2022-08-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-enhertu-accelerated-approval-used-project-optimus-advice 2022-08-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-first-medicare-price-negotiations-begin-in-october-2023-on-inaugural-cohort-of-10-selected-drugs-as-the-inflation-reduction-act-heads-to-white-house-for-signing 2022-08-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-sweeping-drug-pricing-reforms-become-law-as-president-biden-signs-inflation-reduction-act-aug-16 2022-08-17 weekly 0.9 https://staging.previsionpolicy.com/cdc-and-fda-discuss-decolonization-data-to-support-products-to-prevent-healthcare-associated-infections-cdc-is-pushing-for-advice-on-types-of-studies-to-help-fda-accept-surrogate-endpoints 2022-09-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-bluebird-bio-beti-cel-zynteglo-fda-approval 2022-08-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-icer-advisory-panel-review-of-amylyx-mitsubishi-als-drugs-today-may-include-rwd-study 2022-08-19 weekly 0.9 https://staging.previsionpolicy.com/pfdd/complement-3-glomerulopathy 2022-08-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-acting-ond-chief-of-staff-to-be-khushboo-sharma-as-patrick-frey-leaves-fda-for-amgen 2022-08-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ipsen-s-palovarotene-heads-to-the-endocrinologic-metabolic-drugs-advisory-committee-oct-31 2022-08-22 weekly 0.9 https://staging.previsionpolicy.com/cber-brings-in-former-merck-exec-kaslow-to-lead-vaccines-office-allowing-director-marks-to-re-prioritize 2022-09-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-short-term-user-fee-extension-congress-is-considering 2022-09-09 weekly 0.9 https://staging.previsionpolicy.com/coa-development-reframed-by-pfdd-draft-guidance-fda-looking-for-evidence-based-rationale-does-not-expect-major-changes-in-supporting-data 2022-09-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-otc-switch-of-contraception-drug-opill-goes-to-a-joint-fda-advisory-committee-nov-18 2022-09-12 weekly 0.9 https://staging.previsionpolicy.com/amylyx-als-drug-gets-positive-review-by-icer-ahead-of-second-fda-advisory-panel-icer-group-finds-expected-launch-price-too-high 2022-08-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pfizer-biontech-covid-19-ba-4-5-bivalent-vaccine-doses-will-be-ready-for-september-delivery 2022-08-23 weekly 0.9 https://staging.previsionpolicy.com/fda-will-allow-cost-distribution-for-manufacturing-administrative-startup-for-expanded-access-programs-updated-guidance-says 2022-08-23 weekly 0.9 https://staging.previsionpolicy.com/ira-has-not-negated-need-for-part-b-drug-pricing-reforms-medpac-says-proposals-moving-forward-but-congress-may-not-agree 2022-09-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-looks-to-broad-consortia-to-stimulate-progress-in-evidence-generation 2022-08-24 weekly 0.9 https://staging.previsionpolicy.com/biden-as-the-biotech-president-biomanufacturing-executive-order-fits-uneasily-alongside-price-reduction-rhetoric-in-moonshot-events 2022-09-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-advisory-committee-review-of-ced-criteria-scheduled-for-dec-7 2022-09-13 weekly 0.9 https://staging.previsionpolicy.com/drug-quantity-reporting-fda-encourages-manufacturers-to-submit-despite-absence-of-firm-deadline-data-will-prioritize-inspections-mitigate-shortages 2022-09-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-wants-more-notice-before-advisory-committee-members-appear-on-behalf-of-individual-sponsors 2022-09-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicare-advantage-prior-authorization-overhaul-clears-house-part-d-drugs-exempt 2022-09-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-continuing-resolution-expected-to-be-introduced-next-week-with-user-fees-attached 2022-09-16 weekly 0.9 https://staging.previsionpolicy.com/fda-outlines-labeling-applications-for-functional-medical-queries-at-duke-meeting-standardization-for-pre-market-safety-analytics-is-key-goal 2022-09-16 weekly 0.9 https://staging.previsionpolicy.com/ira-reset-gene-therapies-have-price-model-to-dodge-drug-price-negotiation-program-for-negotiated-products-who-negotiates-matters 2024-08-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-director-marks-pressed-then-fda-commissioner-hahn-on-covid-vaccine-eua-guidance-decision 2022-08-25 weekly 0.9 https://staging.previsionpolicy.com/fda-act-for-als-action-plan-will-support-drug-development-in-real-time-agency-outlines-first-steps-in-five-year-implementation 2022-08-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-talking-points-on-drug-pricing-reform-implementation-emphasize-insulin-co-pay-cap-and-premium-subsidies 2022-08-26 weekly 0.9 https://staging.previsionpolicy.com/one-in-five-essential-medicine-api-manufacturers-are-us-based-fda-report-finds-agency-continues-to-benefit-from-remote-inspections 2022-08-26 weekly 0.9 https://staging.previsionpolicy.com/bluebird-bio-zynteglo-15-year-follow-up-is-lengthy-but-builds-on-existing-work-fda-reiterates-preference-for-clinical-benefit-endpoints 2022-08-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-dashboard-of-part-d-drug-payments-offers-guide-to-first-10-blockbusters 2022-08-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-rejects-san-rocco-citizen-petition-asking-for-an-investigation-attempting-to-stop-bluebird-bio-zynteglo-licensure 2022-08-30 weekly 0.9 https://staging.previsionpolicy.com/migraine-prevention-chronic-pain-treatment-guidances-added-to-fda-2022-agenda 2022-08-30 weekly 0.9 https://staging.previsionpolicy.com/prevent-pandemics-act-pushed-by-senate-help-leadership-monkeypox-response-shows-need-for-clear-consistent-authority-sen-burr-says 2022-09-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-novo-nordisk-glp-1s-wegovy-saxenda-fall-outside-icer-cost-effectiveness-range 2022-08-31 weekly 0.9 https://staging.previsionpolicy.com/covid-19-bivalent-vaccine-authorized-by-fda-clinical-data-coming-in-two-months-agency-choosing-to-retain-original-formula-for-primary-series 2022-08-31 weekly 0.9 https://staging.previsionpolicy.com/fda-commissioner-califf-in-hot-seat-over-monkeypox-response-delayed-jynneos-vaccine-doses-topic-at-senate-help-hearing 2022-09-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-rmat-designation-success-rate-is-37-for-cell-gene-therapies-cber-otat-director-wilson-bryan-says 2022-09-26 weekly 0.9 https://staging.previsionpolicy.com/re-examining-mandatory-prescriber-education-opioid-approval-standards-are-priorities-in-fda-opioid-overdose-prevention-framework 2022-09-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-y-mabs-omburtamab-for-neuroblastoma-heads-to-odac-oct-28-attempt-to-recover-from-refuse-to-file-letter 2022-09-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-astrazeneca-avillion-asthma-rescue-inhaler-pt-027-set-for-advisory-committee-review-nov-8 2022-09-02 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-fda-calendar-for-fall-filling-up-with-five-new-meetings-two-re-submissions-add-to-list-of-troubled-reviews 2022-09-02 weekly 0.9 https://staging.previsionpolicy.com/amylyx-take-two-fda-reviewers-still-unpersuaded-by-amx0035-efficacy-but-framing-for-advisory-committee-invites-more-favorable-consideration-of-unmet-need-in-als 2022-09-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-amylyx-amx0035-returns-to-committee-fda-still-unconvinced-of-efficacy-in-als 2022-09-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-veru-sabizabulin-eua-for-high-risk-covid-patients-set-for-advisory-committee 2022-09-07 weekly 0.9 https://staging.previsionpolicy.com/conditional-approval-comes-to-us-amylyx-amx0035-for-als-may-test-informal-approach-after-positive-committee-vote-and-sponsor-pledge-to-pull-nda-if-next-trial-fails 2022-09-08 weekly 0.9 https://staging.previsionpolicy.com/rebiotix-microbiome-enema-rebyota-fda-asks-committee-to-review-bayesian-attempt-to-make-single-phase-3-study-adequate 2022-09-21 weekly 0.9 https://staging.previsionpolicy.com/pediatric-ethical-considerations-guidance-outlines-prospect-of-direct-benefit-and-minimal-risk-criteria 2022-09-26 weekly 0.9 https://staging.previsionpolicy.com/the-future-of-patient-focused-drug-development-fda-s-mullin-proposes-national-catalogue-of-coas 2022-09-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-user-fee-funding-secure-but-cr-sets-up-eventful-lame-duck-session 2022-09-27 weekly 0.9 https://staging.previsionpolicy.com/bluebird-opens-aa-pathway-for-gene-therapies-with-skysona-cald-approval-fda-appears-to-have-pushed-accelerated-route 2022-09-21 weekly 0.9 https://staging.previsionpolicy.com/creates-act-path-for-obtaining-brand-samples-outlined-in-fda-draft-guidance-covered-product-authorization-replaces-safety-determination-letter 2022-09-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-accelerated-approval-comes-to-gene-therapy-bluebird-skysona 2022-09-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-pushes-back-veru-sabizabulin-covid-antiviral-advisory-committee-review 2022-09-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-reviewing-status-of-gsk-zejula-recurrent-ovarian-cancer-indication 2022-09-21 weekly 0.9 https://staging.previsionpolicy.com/biosimilar-development-comparative-clinical-studies-are-a-blunt-tool-that-is-still-needed-though-fda-sees-a-future-without-them 2022-09-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-accelerated-approval-on-ramp-off-ramp-strategies-uncertain-relationship-of-response-rate-to-survival 2022-09-22 weekly 0.9 https://staging.previsionpolicy.com/fda-user-fee-reauthorization-secured-but-continuing-resolution-sets-up-lively-lame-duck-session-in-december-which-if-any-policy-riders-will-make-the-cut 2022-09-27 weekly 0.9 https://staging.previsionpolicy.com/icer-obesity-class-review-could-impact-potential-changes-to-coverage-rules-advocates-say-panel-does-not-see-novo-s-wegovy-as-cost-effective 2022-09-22 weekly 0.9 https://staging.previsionpolicy.com/secura-s-copiktra-fda-re-evaluation-of-benefit-risk-profile-in-light-of-adverse-survival-data-aimed-at-pulling-regular-approval 2022-09-23 weekly 0.9 https://staging.previsionpolicy.com/fda-gene-therapy-user-fee-boost-is-well-timed-but-staff-crunch-may-linger-new-super-office-status-could-help-with-hiring 2022-09-27 weekly 0.9 https://staging.previsionpolicy.com/ogd-in-transition-heading-into-gdufa-iii-fda-veteran-rosencrance-will-be-interim-head-following-director-choe-s-departure 2022-09-27 weekly 0.9 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https://staging.previsionpolicy.com/advisory-committee-tracker-non-inferiority-will-be-theme-of-early-2023-reviews-of-eylea-pediatric-trial-and-cidara-melinta-antifungal 2022-11-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-genentech-pulls-tecentriq-urothelial-carcinoma-indication-following-through-on-timeline 2022-11-29 weekly 0.9 https://staging.previsionpolicy.com/pfdd/hyperhidrosis 2022-11-04 weekly 0.9 https://staging.previsionpolicy.com/avillion-astrazeneca-asthma-rescue-inhaler-combo-budesonide-albuterol-appears-headed-to-approval-fda-wants-advisory-committee-input-on-pediatric-use 2022-11-04 weekly 0.9 https://staging.previsionpolicy.com/veru-sabizabulin-severe-covid-mortality-benefit-likely-strong-enough-to-support-eua-but-fda-wants-repeat-of-study-as-condition-for-authorization 2022-11-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-part-b-discarded-drug-rebate-deadline-will-align-with-inflation-rebates-cms-says 2022-11-08 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https://staging.previsionpolicy.com/fda-advancing-real-world-evidence-program-offers-early-feedback-on-rwe-plans-to-support-new-indications-disclosure-agreement-is-required 2022-10-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-finalizes-multi-endpoints-guidance 2022-10-20 weekly 0.9 https://staging.previsionpolicy.com/makena-withdrawal-vote-underscores-accelerated-approval-integrity-but-process-suggests-fighting-fda-can-pay-off-for-some-sponsors 2022-10-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-neurodegenerative-gene-therapy-development-final-guidance-has-few-changes 2022-10-21 weekly 0.9 https://staging.previsionpolicy.com/cber-status-report-cell-gene-therapy-and-blood-products-work-getting-back-toward-normal-but-pandemic-strain-still-heavy-on-vaccines-director-marks-says 2022-10-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-planning-spring-2023-workshop-with-aacr-on-use-of-overall-survival-analyses 2022-11-10 weekly 0.9 https://staging.previsionpolicy.com/veru-sabizabulin-eua-turned-down-by-fda-advisory-committee-small-database-outweighs-large-mortality-benefit-in-covid-trial 2022-11-10 weekly 0.9 https://staging.previsionpolicy.com/az-avillion-budesonide-albuterol-rescue-inhaler-headed-for-approval-in-adults-after-fda-committee-review-pediatric-indication-likely-needs-more-data 2022-11-10 weekly 0.9 https://staging.previsionpolicy.com/cder-arc-rare-disease-program-takes-shape-cber-plans-warp-speed-style-pilot-in-coming-year 2022-10-24 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-otc-oral-contraceptive-nda-will-put-fda-committees-back-in-political-spotlight-odac-to-consider-another-withdrawal 2022-11-11 weekly 0.9 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https://staging.previsionpolicy.com/aduhelm-congressional-report-provides-anticlimactic-coda-to-fda-controversy-clarifying-use-of-point-counterpoint-briefing-document-may-be-one-outcome 2023-01-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lilly-s-donanemab-for-alzheimer-s-gets-crl-for-accelerated-approval-but-may-mean-little-if-timeline-holds 2023-01-20 weekly 0.9 https://staging.previsionpolicy.com/accelerated-approval-for-gene-therapies-otat-town-hall-suggests-pathway-viable-in-slowly-progressive-disease-with-clear-natural-history 2023-02-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-rems-content-format-final-guidance-from-fda 2023-01-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-seven-years-war-fabre-kramer-submits-nda-amendment-for-gepirone-seven-years-after-dispute-resolution 2023-01-05 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-another-unusual-odac-set-for-february-covid-vaccines-ipledge-rems-will-also-be-topics-early-in-2023 2023-01-05 weekly 0.9 https://staging.previsionpolicy.com/eylea-pediatric-use-fda-asks-committee-for-closer-look-at-proposed-label-for-infant-retinopathy-agency-may-want-more-post-treatment-monitoring 2023-01-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-narcan-otc-will-be-reviewed-by-fda-advisory-committee-broader-implications 2023-01-06 weekly 0.9 https://staging.previsionpolicy.com/fda-inspection-authority-provisions-in-fdora-may-help-make-2023-a-happy-new-year-for-agency 2023-01-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-eisai-biogen-lecanemab-leqembi-clears-fda-but-medicare-coverage-will-await 2023-01-09 weekly 0.9 https://staging.previsionpolicy.com/highlights-from-ucsf-stanford-cersi-summit-fda-s-califf-s-on-legislative-victories-cms-on-lecanemab-path-to-coverage-orbis-for-gene-therapy 2023-01-09 weekly 0.9 https://staging.previsionpolicy.com/cidara-melinta-s-antifungal-rezafungin-likely-to-have-limited-use-indication-only-ad-comm-told-that-fda-does-not-believe-broader-claim-for-candidiasis-is-supported-by-available-data 2023-01-20 weekly 0.9 https://staging.previsionpolicy.com/fda-sticks-to-orphan-drug-exclusivity-by-indication-despite-catalyst-ruling-clarity-for-now-but-more-litigation-likely 2023-01-23 weekly 0.9 https://staging.previsionpolicy.com/covid-vaccines-moving-to-flu-model-fda-advisory-committee-will-be-asked-to-ratify-simplified-annual-strain-selection-process 2023-01-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-makena-gets-closer-to-forced-withdrawal-presiding-officer-celia-witten-agrees-with-cder-hearing-outcome 2023-01-24 weekly 0.9 https://staging.previsionpolicy.com/cms-and-accelerated-approval-pricing-demos-under-discussion-but-there-is-no-simple-answer-aduhelm-policy-is-unique-circumstance-agency-tells-nasem-workshop 2023-03-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-covid-direct-to-final-guidance-clean-up-agency-withdraws-propofol-re-packaging-policy 2023-02-09 weekly 0.9 https://staging.previsionpolicy.com/the-part-d-baseline-medpac-will-be-watching-for-impact-of-plan-changes-on-beneficiary-access-and-choices-during-ira-implementation-period 2023-01-24 weekly 0.9 https://staging.previsionpolicy.com/fda-advisory-committee-trends-rejections-continue-to-dominate-in-2022-will-climate-for-sponsors-change-in-2023 2023-01-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-missouri-rep-jason-smith-will-chair-house-ways-and-means-committee 2023-01-10 weekly 0.9 https://staging.previsionpolicy.com/fda-chiefs-chat-former-commissioners-debate-impact-of-ira-on-drug-development-linking-accelerated-approval-to-reimbursement 2023-01-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-another-aa-review-by-odac-genentech-polivy-will-be-reviewed-march-9-for-first-line-indication 2023-01-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-democrats-establish-committee-membership-with-new-jersey-s-frank-pallone 2023-01-26 weekly 0.9 https://staging.previsionpolicy.com/cidara-melinta-s-rezafungin-on-track-to-be-first-limited-use-antifungal-after-positive-committee-vote-once-weekly-dosing-viewed-as-clear-clinical-advantage 2023-01-26 weekly 0.9 https://staging.previsionpolicy.com/fdora-odds-and-ends-covid-product-transition-will-be-test-case-for-rwe-fda-operations-addressed-via-numerous-provisions 2023-01-10 weekly 0.9 https://staging.previsionpolicy.com/fda-s-very-big-year-a-guide-to-legislation-enacted-in-2022 2023-01-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-second-naloxone-otc-application-heads-to-advisory-committee-march-20 2023-01-27 weekly 0.9 https://staging.previsionpolicy.com/fda-sponsor-communication-to-be-subject-of-house-e-c-hearings-advisory-committees-inspections-among-other-questions-for-califf-during-covid-hearing 2023-02-09 weekly 0.9 https://staging.previsionpolicy.com/pharma-patent-competition-bills-return-in-senate-bipartisan-talks-continue-on-scope-of-ftc-authorities 2023-02-09 weekly 0.9 https://staging.previsionpolicy.com/fda-punts-to-congress-on-cbd-regulation-new-pathway-debate-will-reinforce-likelihood-that-broader-drug-regulatory-topics-stay-out-of-political-spotlight 2023-01-27 weekly 0.9 https://staging.previsionpolicy.com/fda-wants-more-covid-19-manufacturers-at-the-table-simplified-vaccine-campaign-will-help-cber-s-marks-says 2023-01-27 weekly 0.9 https://staging.previsionpolicy.com/tgt-s-ms-agent-briumvi-may-have-some-convenience-advantage-over-genentech-s-ocrevus-icer-panel-says-but-low-value-versus-generic-tecfidera 2023-01-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biopharma-congress-is-two-weeks-away-on-feb-13-cber-director-peter-marks 2023-01-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-gene-therapy-review-office-will-have-new-director-wilson-bryan-is-retiring-in-march 2023-01-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-s-wilson-bryan-to-discuss-evolution-of-otat-to-super-office-at-feb-13-biopharma-congress 2023-01-11 weekly 0.9 https://staging.previsionpolicy.com/fda-plans-to-finalize-otc-safe-use-pathway-in-2023-updated-regulatory-agenda-says 2023-01-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-updating-guidance-on-dosage-administration-section-of-labeling 2023-01-12 weekly 0.9 https://staging.previsionpolicy.com/cber-gene-therapy-super-office-transition-includes-new-leadership-otat-director-wilson-bryan-to-step-down-in-coming-weeks 2023-01-31 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-fda-has-busy-start-to-2023-agenda-includes-als-drug-two-rsv-vaccines-another-unusual-odac-and-opioid-response-topics 2023-01-31 weekly 0.9 https://staging.previsionpolicy.com/regeneron-eylea-pediatric-use-labeling-review-unusual-task-for-fda-advisory-committee-goes-well-for-vegf-inhibitor 2023-01-12 weekly 0.9 https://staging.previsionpolicy.com/fda-gets-granular-on-dose-labeling-new-guidance-on-dosage-administration-section-dramatically-expands-advice-and-examples-from-2010-predecessor 2023-01-12 weekly 0.9 https://staging.previsionpolicy.com/medicare-price-negotiation-implementation-timeline-unveiled-by-cms-small-biotech-exception-is-first-action-item-overall-guidance-due-by-summer 2023-01-12 weekly 0.9 https://staging.previsionpolicy.com/patient-focused-drug-development-for-big-diseases-diabetes-meeting-offers-case-study-important-opportunity-for-sponsors 2023-01-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-opens-national-coverage-review-of-viiv-s-apretude-for-prep 2023-01-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-dose-optimization-draft-guidance-for-cancer-drugs-builds-on-oce-s-project-optimus-not-for-gene-and-cell-therapies 2023-01-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-commissioner-robert-califf-to-keynote-biopharma-congress-on-february-13-fdora-impacts-of-the-ira 2023-02-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-s-califf-faces-first-gop-oversight-hearing 2023-02-01 weekly 0.9 https://staging.previsionpolicy.com/fda-office-of-regulatory-affairs-role-will-change-as-part-of-broader-restructuring-focused-on-food-safety-details-tbd 2023-02-01 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https://staging.previsionpolicy.com/prevision-policy-clips-cber-deputy-celia-witten-will-lead-office-of-therapeutic-products 2023-02-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-judiciary-committee-will-mark-up-pharma-bills 2023-02-07 weekly 0.9 https://staging.previsionpolicy.com/fda-s-otc-paradigm-cannot-begin-until-acnu-rule-is-final-additional-condition-for-nonprescription-use-is-not-third-class-in-disguise 2023-02-07 weekly 0.9 https://staging.previsionpolicy.com/gsk-s-jemperli-odac-may-be-public-test-case-for-accelerated-approval-development-meetings-committee-to-discuss-novel-endpoints-at-ind-stage 2023-02-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-drug-pricing-demos-announced-by-hhs-but-implementation-timeline-and-details-are-still-tbd 2023-02-15 weekly 0.9 https://staging.previsionpolicy.com/uspto-fda-coordination-on-patents-first-practical-politically-palatable-lesson-may-be-for-pto-to-adopt-fda-processes-for-soliciting-patient-perspective 2023-02-10 weekly 0.9 https://staging.previsionpolicy.com/gsk-jemperli-accelerated-approval-in-rectal-cancer-is-possible-with-tweaks-to-proposed-plan-fda-committee-says-model-for-aa-plans 2023-02-10 weekly 0.9 https://staging.previsionpolicy.com/fda-advisory-committees-moving-to-in-person-meetings-califf-envisions-earlier-big-picture-topics-for-discussion-less-gladiator-type-approval-votes 2023-02-16 weekly 0.9 https://staging.previsionpolicy.com/project-orbis-update-71-orbis-approvals-and-counting-since-program-began-in-2019 2023-02-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-working-on-warp-speed-for-rare-diseases-director-peter-marks 2023-02-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-listening-session-on-cell-gene-therapy-data-collection-from-rwe-registries 2023-02-14 weekly 0.9 https://staging.previsionpolicy.com/cms-considering-new-approaches-for-gene-therapy-in-medicaid-but-not-asp-or-protected-class-changes-coo-blum-calls-for-data-on-ira-impact-on-innovation 2023-02-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-moderna-to-testify-at-senate-help-committee-on-covid-vaccine-pricing-plans 2023-02-16 weekly 0.9 https://staging.previsionpolicy.com/cmmi-drug-pricing-models-2-generics-ready-to-go-centralized-gene-therapy-contracts-may-support-scd-launches-can-cms-help-accelerated-approval 2023-02-16 weekly 0.9 https://staging.previsionpolicy.com/fda-s-califf-calls-for-return-to-large-simple-trials-without-useless-stuff-that-slows-development-praises-oce-s-project-pragmatica 2023-02-16 weekly 0.9 https://staging.previsionpolicy.com/fda-gene-therapy-reorg-industry-should-expect-a-year-or-two-for-staffing-to-catch-up-with-demand-policy-plans-include-platform-efforts-inspired-by-warp-speed-rtor-and-orbis 2023-02-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-office-of-oncologic-diseases-deputy-director-slot-vacant-after-julia-beaver-departs 2023-02-17 weekly 0.9 https://staging.previsionpolicy.com/emergent-s-narcan-nasal-spray-unanimously-supported-for-otc-use-set-to-be-first-nonprescription-opioid-reversal-agent-and-first-of-its-kind-fda-initiated-public-health-switch 2023-02-17 weekly 0.9 https://staging.previsionpolicy.com/the-will-vs-the-wait-cber-s-marks-otat-s-bryan-give-differing-views-of-accelerated-approval-for-gene-therapies 2023-02-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pfizer-will-present-on-three-vaccine-candidates-during-february-acip-meeting 2023-02-21 weekly 0.9 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https://staging.previsionpolicy.com/accelerated-approval-changes-in-fdora-play-well-at-nasem-workshop-fda-planning-multiple-guidances-says-authority-in-statute-will-help-with-confirmatory-trials 2023-03-20 weekly 0.9 https://staging.previsionpolicy.com/the-competing-legacies-of-aduhelm-fda-feels-vindicated-but-expanding-role-of-accelerated-approval-depends-on-heeding-calls-for-more-transparency 2023-03-20 weekly 0.9 https://staging.previsionpolicy.com/fda-oncology-dose-optimization-guidance-randomize-where-feasible-breakthrough-status-does-not-obviate-obligation-to-find-optimal-dose-pre-approval 2023-09-08 weekly 0.9 https://staging.previsionpolicy.com/pfizer-gsk-rsv-vaccine-candidates-tandem-reviews-to-showcase-fda-post-covid-vaccine-work-and-leadership 2023-02-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-office-of-compliance-director-jill-furman-will-stay-on 2023-02-27 weekly 0.9 https://staging.previsionpolicy.com/fda-evidence-generation-taxonomy-gene-editing-information-sharing-initiatives-unveiled-by-commissioner-califf-as-second-year-priorities 2023-02-27 weekly 0.9 https://staging.previsionpolicy.com/drug-shortages-back-in-congressional-spotlight-fda-essential-medicine-list-may-need-rethinking-quality-ratings-get-a-boost-from-testimony-at-senate-hearing 2023-03-24 weekly 0.9 https://staging.previsionpolicy.com/fda-neurology-office-deputy-buracchio-is-acting-head-following-dunn-s-exit-consistency-a-plus-but-another-neurologist-bites-the-dust 2023-02-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-liver-drug-division-acting-director-is-frank-anania 2023-02-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-astrazeneca-msd-s-lynparza-goes-to-fda-advisory-committee-for-first-line-metastatic-prostate-cancer 2023-03-01 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-az-merck-lynparza-prostate-cancer-review-extended-for-odac-paxlovid-nda-conversion-heads-to-panel 2023-03-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-updates-drug-spending-dashboards-with-2021-data-but-cautions-against-direct-read-through-for-negotiations 2023-03-02 weekly 0.9 https://staging.previsionpolicy.com/fda-artificial-intelligence-in-drug-manufacturing-discussion-paper-raises-the-issue-that-data-management-practices-may-affect-inspections 2023-03-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-s-revamped-manufacturing-inspections-platform-will-launch-in-2024 2023-03-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-leqembi-advisory-committee-review-will-be-another-accelerated-approval-milestone 2023-03-06 weekly 0.9 https://staging.previsionpolicy.com/gsk-rsv-vaccine-arexvy-two-strong-votes-by-fda-committee-are-tempered-by-repeated-suggestions-to-wait-for-second-year-data 2023-03-06 weekly 0.9 https://staging.previsionpolicy.com/return-of-the-ipi-medpac-members-urge-more-work-on-part-b-pricing-after-current-set-of-recommendations-is-done-excessive-price-authority-is-theme-to-watch 2023-03-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-200-bil-more-biden-budget-proposal-would-increase-number-of-medicare-negotiation-eligible-drugs-speed-up-timelines 2023-03-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-otsuka-lundbeck-rexulti-for-alzheimer-s-agitation-gets-fda-advisory-committee-review 2023-04-04 weekly 0.9 https://staging.previsionpolicy.com/pbm-formulary-design-is-one-focus-of-broad-request-by-gop-house-committee-to-cvs-express-scripts-and-optum-gpo-affiliates-also-draw-questions 2023-03-07 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-rexulti-for-alzheimer-s-agitation-long-awaited-nash-review-among-half-dozen-new-topics-added-by-fda 2023-04-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-director-marks-expects-pace-of-gene-therapy-approvals-to-jump-substantially 2023-04-05 weekly 0.9 https://staging.previsionpolicy.com/gene-therapy-bla-review-teams-will-stay-together-as-office-of-therapeutic-products-launches-feb-26-communication-pilot-will-be-early-highlight 2023-03-07 weekly 0.9 https://staging.previsionpolicy.com/the-new-part-d-cbo-estimates-net-drug-spending-will-decline-by-42-billion-with-all-ira-changes-factored-in-savings-estimates-assume-average-50-cut-for-negotiated-prices 2023-03-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pragmatica-lung-phase-3-advanced-nsclc-survival-trial-with-cyramza-keytruda 2023-04-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-covis-admits-defeat-on-makena-but-still-hoping-to-set-timeline-for-withdrawal 2023-03-08 weekly 0.9 https://staging.previsionpolicy.com/cell-therapy-assessment-aid-would-encourage-use-of-data-extrapolation-for-next-generation-oncology-indications-cber-is-open-to-idea 2023-03-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-opioid-bill-would-require-manufacturers-and-distributors-to-report-suspicious-orders 2023-03-09 weekly 0.9 https://staging.previsionpolicy.com/hcv-subscription-model-is-11-bil-silver-lining-for-drug-developers-in-white-house-budget-price-cuts-are-much-bigger-item-but-far-less-viable 2023-03-10 weekly 0.9 https://staging.previsionpolicy.com/ipledge-rems-review-fda-floats-end-to-use-of-at-home-pregnancy-tests-but-wants-committee-to-consider-loosening-other-isotretinoin-requirements 2023-03-24 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-gao-advanced-manufacturing-report-spotlights-fda-efforts 2023-03-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-brainstorm-says-fda-to-convene-advisory-committee-for-rtfed-nurown-cell-therapy-for-als 2023-03-27 weekly 0.9 https://staging.previsionpolicy.com/get-ready-to-dance-fda-duke-rwe-negative-controls-meeting-features-two-projects-but-agency-says-activities-are-only-at-the-start 2023-03-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-veterans-affairs-department-to-cover-eisai-biogen-s-leqembi-for-alzheimer-s-but-restricts-use-to-65-and-older 2023-03-14 weekly 0.9 https://staging.previsionpolicy.com/gao-report-spotlights-fda-advanced-manufacturing-initiatives-urges-agency-to-flesh-out-metrics-for-etp-and-frame 2023-03-14 weekly 0.9 https://staging.previsionpolicy.com/pfizer-paxlovid-nda-conversion-complicated-by-lack-of-efficacy-in-vaccinated-populations-approval-still-likely-heading-to-panel-review 2023-03-14 weekly 0.9 https://staging.previsionpolicy.com/part-b-inflation-rebate-list-released-by-cms-no-major-products-affected-first-year-collections-may-not-reach-20-million 2023-04-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-draft-guidance-on-long-acting-local-anesthetics-encourages-data-collection-on-opioid-use 2023-03-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-gene-therapy-super-office-witten-s-interim-director-role-likely-to-run-at-least-into-summer 2023-03-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-otc-switch-of-contraception-drug-opill-advisory-committee-rescheduled-and-expanded 2023-03-28 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-cms-final-part-d-rule-harmonizes-gross-drug-spending-definition 2023-04-06 weekly 0.9 https://staging.previsionpolicy.com/cder-hiring-doing-very-well-director-cavazzoni-says-especially-for-medical-officers-still-needs-for-stats-and-inspectors-otc-office-set-to-rebound 2023-04-06 weekly 0.9 https://staging.previsionpolicy.com/can-fda-save-the-generic-industry-chronic-shortages-are-sign-of-strains-facing-sector-cder-director-warns-statutory-update-may-be-overdue 2023-04-06 weekly 0.9 https://staging.previsionpolicy.com/opioid-overdose-treatments-in-spotlight-at-fda-workshop-agency-hopes-to-spread-message-that-abstinence-is-not-the-only-acceptable-endpoint 2023-03-17 weekly 0.9 https://staging.previsionpolicy.com/biomarker-studies-proposed-for-use-in-labeling-require-subject-level-data-submission-fda-says-in-revised-pkg-guidance-voluntary-program-ending 2023-03-17 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-makena-and-generics-formally-withdrawn-immediately-fda-commissioner-califf-and-chief-scientist-bumpus 2023-04-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-projects-novel-anti-infectives-could-net-213-mil-in-add-on-payments-for-fy-2024 2023-04-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-quantity-reporting-fda-finalizes-exemption-for-single-use-gene-cell-therapy-lots 2023-04-12 weekly 0.9 https://staging.previsionpolicy.com/shortage-notification-guidance-updated-covid-era-message-to-manufacturers-to-err-on-the-side-of-informing-fda-will-continue-post-pandemic 2023-04-12 weekly 0.9 https://staging.previsionpolicy.com/ipledge-19-day-lockout-period-for-isotretinoin-patients-should-be-dropped-fda-committee-says-home-pregnancy-tests-should-continue 2023-03-30 weekly 0.9 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https://staging.previsionpolicy.com/pfizer-s-abrysvo-for-rsv-fda-has-overall-favorable-view-of-vaccine-in-infants-with-strong-efficacy-cber-s-marks-to-participate 2023-05-16 weekly 0.9 https://staging.previsionpolicy.com/sarepta-s-dmd-gene-therapy-wins-close-vote-on-accelerated-approval-advisory-committee-members-cite-patient-videos-as-important-factor-in-decision 2023-05-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pediatric-drug-development-draft-guidances-provide-regulatory-scientific-recommendations 2023-05-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicaid-vbp-agreements-for-gene-cell-therapies-bill-goes-to-full-committee 2023-05-18 weekly 0.9 https://staging.previsionpolicy.com/pbm-bills-advance-in-house-as-part-of-patient-act-340b-transparency-gene-therapy-medicaid-vbp-measures-also-clear-e-c-committee 2023-05-25 weekly 0.9 https://staging.previsionpolicy.com/intercept-oca-for-nash-advisory-committee-review-pits-modest-efficacy-in-unmet-need-against-substantial-safety-risks-seen-by-fda 2023-05-18 weekly 0.9 https://staging.previsionpolicy.com/hba1c-affirmed-as-diabetes-endpoint-of-choice-in-new-fda-draft-guidance-agency-offers-approaches-to-incorporate-hypoglycemia-reduction 2023-05-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-potency-assurance-for-cell-and-gene-therapies-draft-guidance-added-to-cber-agenda 2023-06-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ai-framework-unveiled-by-senate-majority-leader-schumer-to-include-new-legislative-approach-of-ai-insight-forums-in-the-fall 2023-06-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-adjusting-for-covariates-in-rcts-guidance-recap-podcast 2023-05-26 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-astrazeneca-sanofi-rsv-antibody-covid-booster-strategy-meetings-highlight-june-agenda 2023-05-30 weekly 0.9 https://staging.previsionpolicy.com/fda-supports-move-to-monovalent-omicron-xbb-lineage-covid-vaccine-for-coming-year-with-vrbpac-likely-to-go-along-specific-sublineage-is-yet-to-be-determined 2023-06-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-patient-medication-information-proposed-rule-will-third-time-be-a-charm 2023-05-30 weekly 0.9 https://staging.previsionpolicy.com/fda-patient-medication-information-proposal-includes-five-year-phase-in-for-all-drugs-to-have-one-page-summaries-best-practices-partnership-suggested-rather-than-consumer-testing-mandate 2023-05-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-oce-director-pazdur-exploring-temporary-importation-of-cancer-drugs-in-shortage-raises-idea-of-buffer-stockpile 2023-05-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-leqembi-coverage-will-be-supported-by-nationwide-cms-facilitated-portal 2023-06-01 weekly 0.9 https://staging.previsionpolicy.com/pfizer-s-abrysvo-rsv-vaccine-in-infants-clears-vrbpac-despite-concerns-about-premature-deliveries-co-administration-cber-s-marks-chimes-in-at-the-end 2023-05-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-former-cms-chief-of-staff-mandy-cohen-to-be-next-cdc-director 2023-06-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-otp-hiring-update-acting-director-witten-estimates-40-employees-hired-at-new-super-office-since-mid-february 2023-05-19 weekly 0.9 https://staging.previsionpolicy.com/cber-stepping-up-effort-as-regulator-stimulator-of-gene-therapy-commercial-efforts-marks-says-it-is-frustrating-to-see-late-stage-projects-dropped 2023-05-19 weekly 0.9 https://staging.previsionpolicy.com/cber-will-take-more-user-friendly-approach-with-clinical-holds-offer-alternatives-to-sponsors-otp-staffing-progressing-well 2023-05-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-first-topical-gene-therapy-krystal-biotech-s-vyjuvek-approved-by-fda-for-rare-skin-disease 2023-05-22 weekly 0.9 https://staging.previsionpolicy.com/warp-speed-for-real-world-evidence-cder-director-cavazzoni-suggests-rwe-adoption-may-require-acceleration-adcom-revamp-takes-shape 2023-05-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-what-s-holding-back-cell-therapies-cber-s-marks-says-artificial-intelligence-can-help 2023-05-23 weekly 0.9 https://staging.previsionpolicy.com/platform-pathway-will-not-be-one-size-fits-all-fda-says-car-t-therapies-may-be-early-models-for-leveraging-data-across-products-focr-white-paper-suggests 2023-05-23 weekly 0.9 https://staging.previsionpolicy.com/fda-migraine-prevention-draft-guidance-confirms-separate-trials-for-episodic-and-chronic-indications-recent-approvals-have-incorporated-that-approach 2023-06-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-j-j-covid-vaccine-withdrawn-from-us-fda-formally-revokes-eua 2023-06-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-brainstorm-says-filed-over-protest-nurown-als-cell-therapy-will-get-fda-panel-review-september-27 2023-06-06 weekly 0.9 https://staging.previsionpolicy.com/intercept-oca-nash-indication-will-wait-for-outcomes-data-attempt-to-win-committee-support-for-accelerated-approval-by-cutting-target-market-fails 2023-05-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicaid-price-verification-survey-proposal-seeks-to-apply-pressure-for-supplemental-rebates-vbp-agreements 2023-05-24 weekly 0.9 https://staging.previsionpolicy.com/fda-advancing-rwe-initiative-offers-all-hands-on-deck-review-of-real-world-data-proposals-first-selections-have-been-made-details-to-come 2023-06-06 weekly 0.9 https://staging.previsionpolicy.com/az-sanofi-s-nirsevimab-for-rsv-fda-highlights-demonstrated-efficacy-better-than-synagis-few-safety-concerns-ahead-of-june-8-advisory-committee-review 2023-06-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-merck-constitutional-challenge-of-ira-drug-price-negotiations 2023-06-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-preparing-for-leqembi-coverage-cms-provides-new-details-about-registry 2023-06-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-oncology-drug-companion-diagnostic-pilot-unveiled-by-fda-through-guidance-agency-will-take-nine-sponsors 2023-06-22 weekly 0.9 https://staging.previsionpolicy.com/fda-takes-first-steps-to-highlight-pediatric-dose-optimization-for-targeted-oncology-drugs-with-advisory-committee-meeting 2023-06-15 weekly 0.9 https://staging.previsionpolicy.com/eisai-biogen-s-leqembi-headed-toward-full-approval-in-alzheimer-s-fda-support-is-unequivocal-committee-makeup-all-but-assures-positive-vote 2023-06-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-intarcia-continues-fight-for-exanatide-twice-yearly-fda-will-hold-september-endocrinologic-and-metabolic-drugs-advisory-committee-hearing 2023-06-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-iilun-murphy-is-permanent-ogd-director-cder-s-corrigan-curay-will-assume-oversight-of-generic-drugs 2023-06-09 weekly 0.9 https://staging.previsionpolicy.com/astrazeneca-sanofi-s-nirsevimab-for-rsv-shines-during-fda-panel-review-four-novel-prevention-options-could-be-available-this-winter 2023-06-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-chamber-of-commerce-sues-hhs-over-ira-drug-price-negotiation-program-making-it-the-second-challenge 2023-06-12 weekly 0.9 https://staging.previsionpolicy.com/fda-rare-disease-endpoint-pilot-will-apply-public-disclosure-lessons-from-cid-pilot-applicants-should-prepare-for-time-resource-commitment 2023-06-12 weekly 0.9 https://staging.previsionpolicy.com/eisai-biogen-s-leqembi-for-alzheimer-s-gets-unanimous-endorsement-from-fda-committee-clearing-way-for-cms-coverage-caution-expressed-about-subgroups 2023-06-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-help-committee-chair-sanders-to-block-health-agency-nominees-until-white-house-produces-comprehensive-drug-pricing-strategy 2023-06-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-partisan-disagreement-on-inclusion-of-supply-chain-transparency-measures-dominates-e-c-pahpa-legislative-hearing 2023-06-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-vrbpac-unanimously-supports-switch-to-monovalent-xbb-covid-vaccines 2023-06-16 weekly 0.9 https://staging.previsionpolicy.com/fda-advanced-manufacturing-technology-pathway-initial-launch-at-year-end-will-likely-be-updated-with-experience-agency-indicates 2023-06-16 weekly 0.9 https://staging.previsionpolicy.com/fda-tells-vaccine-manufacturers-to-start-producing-monovalent-xbb-1-5-covid-vaccines-after-unanimous-vrbpac-vote-cber-s-marks-says-agency-will-stick-to-annual-update-strategy 2023-06-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-bluebird-bio-receives-fda-priority-review-for-lovo-cel-sickle-cell-gene-therapy-dec-20-pdufa-date 2023-06-21 weekly 0.9 https://staging.previsionpolicy.com/sarepta-dmd-gene-therapy-starts-as-product-for-4-5-year-olds-confirmatory-trial-due-in-early-2024-will-be-key-to-possible-label-expansion 2023-06-23 weekly 0.9 https://staging.previsionpolicy.com/cms-coverage-modernization-initiative-will-increase-transparency-in-ced-process-as-medicare-prepares-for-lecanemab-coverage-and-registry 2023-06-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-sarepta-s-elevidys-fda-posts-summary-basis-for-regulatory-action 2023-06-26 weekly 0.9 https://staging.previsionpolicy.com/ipsen-s-palovarotene-for-fop-challenges-from-single-arm-trial-may-be-too-many-for-fda-panel-to-overcome-but-agency-leaves-the-door-open-for-a-yes 2023-06-26 weekly 0.9 https://staging.previsionpolicy.com/fda-oncology-center-establishes-key-design-and-data-elements-for-rwd-initial-study-proposals-under-oncology-qcard-initiative 2023-06-27 weekly 0.9 https://staging.previsionpolicy.com/psychedelic-clinical-investigations-draft-guidance-outlines-complementary-designs-to-traditional-placebo-trials-addresses-dose-response-valvulopathy-and-psychological-intervention 2023-06-28 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-genentech-blueprint-withdraw-gavreto-pralsetinib-accelerated-approval-for-advanced-medullary-thyroid-cancer 2023-07-03 weekly 0.9 https://staging.previsionpolicy.com/cms-adds-patient-sessions-to-negotiation-process-to-address-therapeutic-alternatives-revised-ira-guidance-continues-narrow-protection-for-orphan-drugs 2023-07-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-help-pahpa-discussion-draft-includes-disease-x-act-policies-outside-the-staff-agreement-for-stakeholder-feedback 2023-07-05 weekly 0.9 https://staging.previsionpolicy.com/pahpa-reauthorization-draft-includes-disease-x-provision-but-supply-chain-transparency-measures-valid-and-antibiotic-development-incentives-are-out 2023-07-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cell-and-gene-therapy-nonclinical-assessment-cber-schedules-town-hall-event-for-aug-30 2023-07-06 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-lovo-cel-v-exa-cel-sickle-cell-gene-therapies-icer-advisory-group-finds-no-difference 2023-07-28 weekly 0.9 https://staging.previsionpolicy.com/exclusivity-extension-for-shelf-life-studies-is-among-carrots-for-industry-in-house-gop-shortage-bill-inflation-rebate-relief-also-proposed-as-is-potential-route-to-part-b-reimbursement-reform 2023-07-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-gop-drug-shortage-bill-leans-in-to-incentives-for-manufacturers-one-month-exclusivity-extension 2023-07-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-part-d-average-premium-set-to-decline-in-2024-even-as-benefit-becomes-more-generous 2023-08-01 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-alnylam-onpattro-snda-brainstorm-filed-over-protest-bla-offer-contrasting-rare-disease-reviews-for-september 2023-08-01 weekly 0.9 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https://staging.previsionpolicy.com/office-of-therapeutic-products-director-verdun-is-a-cber-veteran-internal-candidate-chosen-for-high-profile-post-overseeing-gene-cell-therapy-reviews 2023-08-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-otp-director-nicole-verdun-highlights-past-gene-therapy-experience-importance-of-stakeholder-engagement 2023-08-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-az-sanofi-beyfortus-enthusiastically-endorsed-by-acip-despite-concern-about-price 2023-08-04 weekly 0.9 https://staging.previsionpolicy.com/the-future-of-os-in-oncology-fda-workshop-focuses-on-challenges-with-survival-endpoints-as-cancer-care-improves-accelerated-approval-is-one-tool-fda-may-use-when-os-is-uncertain 2023-08-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-sage-biogen-zurzuvae-split-decision-by-fda-approves-post-partum-depression 2023-08-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-schedules-listening-session-on-product-recalls-for-sept-29 2023-08-08 weekly 0.9 https://staging.previsionpolicy.com/fda-informed-consent-guidance-sticks-to-themes-of-establishing-safeguards-in-complex-research-populations-but-gives-irbs-flexibility-when-new-information-arises 2023-09-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-releases-quality-management-maturity-program-white-paper 2023-09-01 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-amgen-s-lumakras-poses-another-aa-test-for-odac-fda-will-use-committee-for-intarcia-hearing-but-not-pepaxto 2023-09-01 weekly 0.9 https://staging.previsionpolicy.com/antibiotic-incentives-should-include-unbundling-in-medicare-paratek-ceo-argues-barda-support-for-novel-anthrax-treatment-could-be-model-for-onshoring 2023-09-04 weekly 0.9 https://staging.previsionpolicy.com/qtc-labeling-draft-guidance-for-non-antiarrhythmic-drugs-reasonable-evidence-of-causal-cardiac-events-should-result-in-boxed-warning-fda-says 2023-08-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-postapproval-pregnancy-safety-studies-fda-duke-margolis-workshop-sept-18-19 2023-08-09 weekly 0.9 https://staging.previsionpolicy.com/sickle-cell-gene-therapies-continue-icer-positive-gene-therapy-reviews-past-inequities-create-favorable-context-for-price-coverage 2023-08-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-postmarket-data-collection-guidance-on-underrepresented-populations-features-mechanisms-by-which-fda-can-request-or-require-information 2023-08-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-value-based-purchasing-agreements-in-als-there-s-no-leverage 2023-08-11 weekly 0.9 https://staging.previsionpolicy.com/postmarket-data-collection-guidance-for-underrepresented-groups-provides-broad-fda-advice-on-approaches-real-world-data-among-options 2023-08-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-net-hiring-far-outpacing-cber-with-186-new-hires-compared-to-only-three-net-gains 2023-08-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-us-worldmeds-eflornithine-neuroblastoma-relapse-prevention-nda-will-be-reviewed-by-odac-on-october-4 2023-08-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-az-warning-letter-for-breztri-aerosphere-is-first-issued-by-fda-office-of-prescription-drug-promotion-in-2023 2023-08-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-labeling-for-biosimilar-and-interchangeable-products-draft-guidance-under-review-at-omb 2023-08-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hydroxychloroquine-ephedrine-fail-to-make-fda-503b-bulk-drug-list-for-compounding-by-outsourcing-facilities 2023-08-18 weekly 0.9 https://staging.previsionpolicy.com/biosimilar-supplement-applications-fda-offers-details-on-new-review-categories-under-bsufa-iii 2023-08-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-amgen-lumakras-aa-conversion-application-will-provide-odac-case-study-for-successful-pfs-trial-with-adverse-survival 2023-08-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-part-d-smooth-co-pay-guidance-will-be-issued-in-two-parts-cms-says 2023-08-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-intarcia-fight-to-salvage-exenatide-combo-product-nda-will-go-to-advisory-committee 2023-08-23 weekly 0.9 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https://staging.previsionpolicy.com/rwd-rwe-considerations-guidance-fda-finalizes-december-2021-draft-says-rwe-considerations-will-apply-similarly-to-eua-transition-products-as-well-as-traditionally-developed-products 2023-09-04 weekly 0.9 https://staging.previsionpolicy.com/cms-resists-role-as-rebate-monitor-during-ira-transition-gao-report-confirms-diabetes-blood-thinners-as-highly-rebated-classes-in-part-d 2023-09-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-kimberlee-trzeciak-will-be-fda-s-deputy-commissioner-for-policy-legislation-and-international-affairs 2023-08-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-merck-chronic-cough-drug-gefapixant-will-go-to-fda-s-pulmonary-allergy-drugs-panel-november-17 2023-09-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-price-negotiation-top-10-list-unveiled-j-j-has-three-brands-on-the-list 2023-08-29 weekly 0.9 https://staging.previsionpolicy.com/fda-outlines-deficiencies-in-cell-gene-therapy-inds-amid-criticism-of-increase-in-clinical-holds-otp-director-verdun-delivers-remarks-as-new-super-office-head 2023-09-07 weekly 0.9 https://staging.previsionpolicy.com/fda-human-factors-studies-guidance-finalized-with-new-name-and-format-fda-clarifies-critical-tasks-with-emphasis-on-mis-dosing-time-sensitivity 2023-09-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-generic-drug-shortages-legislative-hearing-in-house-energy-commerce-health-subcommittee-scheduled-for-september-14 2023-09-08 weekly 0.9 https://staging.previsionpolicy.com/real-world-views-on-rwe-recover-trial-on-long-covid-seen-as-us-answer-to-uk-s-recovery-data-sources-are-ongoing-challenge-to-rwe-trial-interpretation 2023-09-08 weekly 0.9 https://staging.previsionpolicy.com/pediatric-oncology-clinical-studies-should-not-wait-for-identification-of-optimal-adult-dose-fda-advisory-committee-advises 2023-09-10 weekly 0.9 https://staging.previsionpolicy.com/hybrid-pre-approval-inspections-will-be-part-of-fda-practice-post-covid-draft-guidance-outlines-plan-to-continue-flexibility-in-using-alternatives-to-traditional-pais 2025-10-08 weekly 0.9 https://staging.previsionpolicy.com/cell-gene-therapy-is-ripe-for-rwd-given-length-of-follow-up-required-abernethy-says-informed-consent-will-need-to-evolve-for-new-data-needs 2023-09-15 weekly 0.9 https://staging.previsionpolicy.com/hepatic-impairment-studies-recommended-for-all-nash-drugs-immunogenicity-labeling-required-for-all-peptide-drugs-fda-says-in-clinical-pharmacology-draft-guidance 2023-09-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-single-trial-efficacy-guidance-details-types-of-evidence-that-could-be-considered-confirmatory 2023-09-18 weekly 0.9 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https://staging.previsionpolicy.com/dose-optimization-in-oncology-drug-combinations-dosing-toolkit-is-next-step-in-project-optimus-to-prepare-sponsors-for-filing-and-avoid-review-delays 2023-09-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-regeneron-substantially-equivalent-ex-us-pricing-clause-in-project-nextgen-agreement-leads-to-nih-pick-bertagnolli-confirmation-hearing-in-october 2023-09-11 weekly 0.9 https://staging.previsionpolicy.com/alnylam-onpattro-for-attr-cm-fda-seeking-cardio-renal-committee-view-on-extent-of-clinically-meaningful-effect-fda-review-team-not-convinced 2023-09-11 weekly 0.9 https://staging.previsionpolicy.com/ora-reorg-to-include-inspectors-trained-in-real-world-evidence-fda-s-califf-says-commissioner-pushes-rwe-to-guide-use-of-alzheimer-s-obesity-drugs 2023-09-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biosimilar-interchangeable-fda-labeling-draft-guidance-builds-on-earlier-general-principles 2023-09-15 weekly 0.9 https://staging.previsionpolicy.com/house-generic-drug-shortage-hearing-shows-discord-over-rebate-incentives-fda-s-role-as-instigator-are-buffer-stocks-a-bipartisan-solution 2023-09-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-changes-therapeutic-equivalence-rating-for-accord-healthcare-s-tacrolimus-generic 2023-09-19 weekly 0.9 https://staging.previsionpolicy.com/otp-director-verdun-outlines-opportunity-for-gene-therapy-platform-technologies-shares-cber-head-marks-vision-for-moving-field-forward 2023-09-19 weekly 0.9 https://staging.previsionpolicy.com/when-one-trial-is-enough-fda-expands-on-options-for-confirmatory-efficacy-evidence-including-rwe-expanded-access 2023-09-19 weekly 0.9 https://staging.previsionpolicy.com/nash-mash-accelerated-approval-fda-remains-confident-in-pathway-for-liver-disease-confirmatory-trials-difficult-but-doable-fda-officials-say-during-biomarker-workshop 2023-09-19 weekly 0.9 https://staging.previsionpolicy.com/intarcia-i2o-itca-650-refuse-to-approve-hearing-draws-out-fda-concerns-over-device-component-safety-committee-likely-to-agree-with-agency 2023-09-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-infected-trials-guidance-reissued-by-fda-covid-advice-on-disruptions-will-carry-forward 2023-09-20 weekly 0.9 https://staging.previsionpolicy.com/biosimilar-clinical-study-streamlining-regulatory-mindset-is-changing-but-fda-policy-updates-will-likely-come-at-measured-pace-in-context-of-global-harmonization 2023-09-20 weekly 0.9 https://staging.previsionpolicy.com/oncology-multi-agent-dosing-strategies-sponsors-can-learn-from-other-drug-classes-anesthesiology-offers-way-to-understand-efficacy-toxicity 2023-09-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-preapproval-inspection-alternatives-fda-draft-guidance-outlines-risk-based-approach 2023-09-21 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-biomarkers-for-allergic-diseases-and-asthma-fda-workshop-february-22 2023-09-22 weekly 0.9 https://staging.previsionpolicy.com/nash-mash-surrogate-endpoints-fda-urges-biomarker-developers-to-rethink-approach-work-together-on-alternatives-to-histology-quantum-of-benefit-is-one-key-theme 2023-09-22 weekly 0.9 https://staging.previsionpolicy.com/price-negotiation-hearing-highlights-industry-push-to-extend-small-molecule-lifespan-broader-orphan-exemption-also-raised 2023-09-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-shutdown-math-over-80-of-fda-staff-would-be-spared 2023-09-25 weekly 0.9 https://staging.previsionpolicy.com/fda-digital-labeling-guidance-affirms-that-most-drug-use-related-software-does-not-require-prior-approval-direct-transfer-of-information-from-product-is-key-consideration 2023-09-25 weekly 0.9 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https://staging.previsionpolicy.com/brainstorm-nurown-for-als-negative-review-from-fda-draws-a-line-for-advisory-committee-after-unprecedented-flexibility-for-other-agents 2023-09-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pfizer-pentavalent-meningococcal-vaccine-recommendation-vote-set-for-upcoming-acip-meeting-oct-25-27 2023-09-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-ntap-town-hall-scheduled-for-december-13-14-for-fy-2025-applications 2023-09-27 weekly 0.9 https://staging.previsionpolicy.com/digital-pathology-use-in-oncology-drug-development-calls-for-fda-guidance-raise-chicken-and-egg-dilemma-who-will-be-first-mover-to-test-new-approaches 2023-09-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-will-fda-lab-developed-test-reg-beat-the-shutdown-omb-has-completed-review 2023-09-28 weekly 0.9 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https://staging.previsionpolicy.com/vertex-exa-cel-off-target-effect-screening-approach-convinces-fda-committee-first-gene-editing-therapeutic-on-track-to-approval 2023-11-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-shutdown-averted-for-now-continuing-resolution-includes-animal-drug-user-fee-reauthorization 2023-10-02 weekly 0.9 https://staging.previsionpolicy.com/warp-speed-for-rare-diseases-cmc-readiness-is-key-criteria-for-cder-cber-start-program 2023-10-02 weekly 0.9 https://staging.previsionpolicy.com/us-worldmeds-eflornithine-for-neuroblastoma-fda-review-showcases-model-for-externally-controlled-trial-to-support-efficacy-tests-single-trial-flexibility 2023-10-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-acrotech-overdue-confirmatory-trials-for-folotyn-and-beleodaq-will-be-focus-of-odac-review 2023-10-03 weekly 0.9 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0.9 https://staging.previsionpolicy.com/rare-disease-review-flexibility-will-be-focus-of-national-academies-report-kick-off-meeting-highlights-disconnect-between-fda-s-perceptions-and-those-of-patients 2023-11-14 weekly 0.9 https://staging.previsionpolicy.com/merck-s-gefapixant-rejected-by-fda-panel-large-placebo-response-small-benefit-sink-chronic-cough-application-despite-relatively-clean-safety-profile 2023-11-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-after-makena-preterm-birth-drug-development-meeting-hosted-by-fda-duke-margolis-scheduled-for-january-23-24 2023-11-21 weekly 0.9 https://staging.previsionpolicy.com/pazdur-s-next-crusade-improving-conduct-during-open-label-trials-to-prevent-bias-amgen-lumakras-will-likely-retain-aa-but-needs-another-confirmatory-trial 2023-10-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-mirati-buyout-by-bristol-follows-odac-kras-review 2023-10-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-office-of-immunology-inflammation-acting-director-is-nikolay-nikolov-after-departure-of-julie-beitz 2023-10-11 weekly 0.9 https://staging.previsionpolicy.com/omics-science-at-fda-commissioner-califf-cautions-against-letting-human-nature-jeopardize-potential-for-systems-biology-to-transform-medicine 2023-10-11 weekly 0.9 https://staging.previsionpolicy.com/us-worldmeds-eflornithine-for-neuroblastoma-on-track-for-milestone-approval-robust-externally-controlled-trial-is-just-strong-enough-to-overcome-fda-panel-s-wariness-about-precedent 2023-10-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cmmi-gene-therapy-model-could-begin-enrolling-states-in-2025-accelerated-approval-demo-will-take-more-time 2023-10-12 weekly 0.9 https://staging.previsionpolicy.com/fda-differs-from-ich-on-thresholds-for-topical-ophthalmic-impurity-identification-qualification-in-quality-considerations-draft-guidance 2023-10-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-expects-consistent-coverage-of-beta-amyloid-pet-scans-in-medicare-following-removal-of-a-2013-national-coverage-decision 2023-10-13 weekly 0.9 https://staging.previsionpolicy.com/tough-love-on-accelerated-approvals-acrotech-s-folotyn-beleodaq-delays-will-not-prompt-withdrawal-but-fda-is-declaring-never-again-in-odac-review 2023-11-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-thank-you-and-have-a-great-day-cms-ends-j-j-xarelto-patient-listening-session-abruptly-with-no-agency-comments-on-what-s-next 2023-11-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-shutdown-deadline-pushed-to-january-19-under-house-continuing-resolution 2023-11-15 weekly 0.9 https://staging.previsionpolicy.com/fda-office-of-immunology-inflammation-enters-new-era-with-acting-director-nikolov-rheumatology-division-replacement-is-ozlem-belen 2023-10-16 weekly 0.9 https://staging.previsionpolicy.com/cmmi-accelerates-timeline-for-gene-therapy-value-based-contracting-model-but-says-accelerated-approval-demo-may-take-more-time-in-update-on-drug-pricing-plans 2023-10-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicare-part-b-biosimilar-payment-enhancement-bill-is-on-agenda-for-house-hearing 2023-10-16 weekly 0.9 https://staging.previsionpolicy.com/fda-is-concerned-that-cmc-work-on-blas-for-cell-gene-therapies-may-not-be-keeping-pace-with-more-rapid-demonstrations-of-clinical-efficacy 2023-11-02 weekly 0.9 https://staging.previsionpolicy.com/orchard-arsa-cel-gene-therapy-for-mld-could-be-cost-effective-at-2-4-million-per-treatment-icer-review-suggests-durability-is-key-variable-in-value-assessment 2023-10-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-nurown-in-als-only-path-forward-is-second-phase-3-study-brainstorm-withdraws-bla 2023-10-18 weekly 0.9 https://staging.previsionpolicy.com/project-pragmatica-update-lung-trial-accruing-well-stakeholders-agree-explicit-assurance-from-fda-on-data-collection-will-encourage-more-pragmatic-studies-in-oncology 2023-10-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-benefit-risk-assessment-final-guidance-includes-minor-clarifying-language-changes 2023-10-19 weekly 0.9 https://staging.previsionpolicy.com/generic-drugs-in-part-d-medpac-digging-into-claims-data-supply-chain-to-understand-price-variability 2023-10-19 weekly 0.9 https://staging.previsionpolicy.com/nih-nominee-bertagnolli-is-noncommittal-on-march-in-for-high-drug-prices-major-changes-in-policy-seem-unlikely-but-will-pricing-clauses-return 2023-10-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-net-prices-instead-of-gross-sales-in-determining-ira-negotiation-selected-drugs-energy-commerce-health-subcommittee-chair-guthrie-expresses-interest 2023-10-20 weekly 0.9 https://staging.previsionpolicy.com/fda-benefit-risk-framework-final-guidance-affirms-decade-old-tool-as-central-to-drug-reviews-revisions-from-draft-emphasize-fda-s-role-as-decider-with-suggestions-for-better-sponsor-input 2023-10-20 weekly 0.9 https://staging.previsionpolicy.com/menopausal-status-is-another-focus-for-fda-trial-inclusion-efforts-chronological-age-alone-is-not-enough-to-rule-out-potential-drug-effects 2023-10-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-revises-draft-guidance-on-manufacturer-communications-of-scientific-information-to-health-care-providers-regarding-unapproved-uses 2023-10-23 weekly 0.9 https://staging.previsionpolicy.com/if-the-siuu-fits-fda-updates-off-label-reprint-guidance-with-broader-scope-five-clearly-stated-principles-and-new-acronym-scientific-information-on-unapproved-uses-siuu 2023-10-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-help-committee-chair-bernie-sanders-i-vt-urges-hhs-inspector-general-to-investigate-proposed-nih-grant-for-cervical-cancer-treatment 2023-10-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-hepatology-division-director-joseph-toerner-returns-from-detail-frank-anania-resumes-as-deputy 2023-10-25 weekly 0.9 https://staging.previsionpolicy.com/resilient-trials-fda-trial-disruption-workshop-stresses-implementation-and-preparation-industry-notes-that-business-case-for-decentralized-trials-is-yet-to-be-proven 2023-10-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-340b-drug-discount-program-outpatient-pharmacy-registration-requirements-restored-with-end-of-covid-public-health-emergency 2023-10-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-receives-stinging-criticism-on-rare-diseases-from-patients-promising-pathway-act-gets-spotlight-at-senate-aging-committee-hearing 2023-10-27 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-odac-deliquent-aa-reviews-resume-with-acrotech-s-folotyn-beleodaq-shutdown-threat-overhangs-future-schedule 2023-10-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-vertex-crispr-exa-cel-advisory-committee-meeting-will-be-targeted-discussion-of-potential-off-target-effects 2023-10-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-sarepta-elevidys-confirmatory-trial-misses-primary-endpoint-but-company-will-seek-label-expansion 2023-10-31 weekly 0.9 https://staging.previsionpolicy.com/cms-price-negotiation-listening-session-for-eliquis-sets-template-for-patient-input-events-pro-negotiation-patients-formulary-placement-are-themes 2023-10-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-entresto-cms-patient-listening-session-has-fewer-patient-speakers-half-are-repeats-with-themes-of-pro-negotiation-and-concerns-over-formulary-restrictions 2023-11-02 weekly 0.9 https://staging.previsionpolicy.com/the-personal-touch-fda-continues-to-view-in-person-inspections-as-more-efficient-than-remote-alternatives-third-country-inspections-will-continue 2023-11-02 weekly 0.9 https://staging.previsionpolicy.com/fda-enters-a-critical-12-months-califf-s-legacy-year-starts-with-shutdown-threat-and-ends-with-presidential-election 2023-10-31 weekly 0.9 https://staging.previsionpolicy.com/cardiovascular-respiratory-drugs-would-test-rebate-pass-through-in-part-d-under-senate-finance-bill-would-also-require-favorable-formulary-status-for-low-cost-biosimilars 2023-11-03 weekly 0.9 https://staging.previsionpolicy.com/continuous-manufacturing-adoption-is-steady-but-slow-fda-updates-cm-progress-frame-and-qmm-at-pharmaceutical-quality-symposium 2023-11-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-real-time-oncology-review-final-guidance-includes-modest-changes-to-2022-draft-version-fda-says 2023-11-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-help-committee-democrats-ask-j-j-bristol-and-merck-ceos-to-appear-january-24 2023-11-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-nih-director-bertagnolli-senate-confirms-nominee-62-36-despite-two-no-votes-from-democrats 2023-11-08 weekly 0.9 https://staging.previsionpolicy.com/rebate-pass-through-bill-heads-to-senate-floor-amendment-directs-gao-to-study-impacts-of-new-policy-cbo-still-sees-costs-going-up-biosimilar-tiering-provision-needs-more-work 2023-11-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-oncology-chief-richard-pazdur-cber-head-peter-marks-headline-the-2024-biopharma-congress-on-february-26 2023-11-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-end-of-an-era-fda-commissioner-califf-to-name-successor-in-the-future-to-principal-deputy-janet-woodcock-following-her-retirement-in-early-2024 2023-11-17 weekly 0.9 https://staging.previsionpolicy.com/project-optimus-update-discussion-has-shifted-from-why-to-how-to-do-dose-optimization-fda-says-friends-of-cancer-research-white-paper-emphasizes-role-for-pros 2023-11-15 weekly 0.9 https://staging.previsionpolicy.com/fda-s-pragmatic-approach-to-pragmatic-cancer-trials-os-is-only-viable-endpoint-for-now-but-pared-down-eligibility-criteria-safety-data-can-be-more-broadly-applied 2023-11-15 weekly 0.9 https://staging.previsionpolicy.com/merck-cough-therapy-gefapixant-review-hinges-on-whether-cough-reduction-is-large-enough-to-be-clinically-meaningful-pros-may-be-key-support-if-committee-agrees 2023-11-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-on-shoring-rx-manufacturing-hhs-plans-35-million-investment 2023-11-28 weekly 0.9 https://staging.previsionpolicy.com/acrotech-confirmatory-study-plan-for-lymphoma-drugs-not-reasonable-odac-says-changes-likely-after-pazdur-arm-twisting-in-latest-accelerated-approval-showcase 2023-11-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-bad-karmma-bristol-2seventybio-abecma-label-expansion-heads-to-advisory-committee-review-extended 2023-11-20 weekly 0.9 https://staging.previsionpolicy.com/dtc-major-statement-rule-finalized-at-last-fda-acknowledges-change-in-technology-since-2010-proposal-but-says-principles-of-clear-conspicuous-and-neutral-still-apply 2023-11-20 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-a-quiet-end-to-a-busy-year 2023-12-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-investigating-car-t-linked-malignancies-affirms-positive-benefit-risk-ratio 2023-11-29 weekly 0.9 https://staging.previsionpolicy.com/fda-deputy-commissioner-will-be-chief-scientist-bumpus-selection-assures-stability-in-everyday-operations-sets-succession-plan-for-potential-biden-second-term 2023-11-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ai-in-drug-development-clinical-trial-design-and-conduct-are-potential-uses-of-artificial-intelligence 2023-11-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-finalizes-340b-drug-repayment-plan-9-billion-lump-sum-payment-will-go-to-providers 2023-11-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-novo-nordisk-s-novolog-fiasp-insulin-device-cms-patient-listening-session-features-overwhelmingly-pro-negotiation-themes 2023-11-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-clinical-trial-remuneration-could-increase-diversity-among-study-populations-fda-office-of-medical-policy-deputy-director-karen-hicks 2023-12-01 weekly 0.9 https://staging.previsionpolicy.com/fda-diversity-plan-analysis-shows-steep-learning-curve-for-oncology-sponsors-only-small-fraction-of-oce-submissions-were-acceptable-in-first-year 2023-11-30 weekly 0.9 https://staging.previsionpolicy.com/diversity-in-clinical-trials-early-planning-to-include-underrepresented-populations-will-prevent-slowdowns-in-drug-development-fda-s-stein-says 2023-12-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-vaccine-review-division-will-be-split-in-two 2023-12-04 weekly 0.9 https://staging.previsionpolicy.com/otp-reorganization-has-increased-review-expertise-in-specialty-disciplines-cber-director-marks-says-live-meeting-interactions-increasing-under-director-verdun 2023-12-05 weekly 0.9 https://staging.previsionpolicy.com/cms-patient-listening-sessions-disappoint-open-public-hearing-approach-yields-little-useful-input-fda-pfdd-model-might-be-better 2023-12-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-data-monitoring-committees-guidance-fda-maintains-recommendations-for-a-charter-detailing-obligations-responsibilities-and-procedures 2024-02-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-bio-head-will-be-amicus-ceo-john-crowley 2023-12-05 weekly 0.9 https://staging.previsionpolicy.com/fda-digital-transformation-entering-more-visible-and-strategic-stage-cio-desai-says-califf-warns-that-siloed-approach-in-government-remains-a-threat-to-overall-vision 2023-12-05 weekly 0.9 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https://staging.previsionpolicy.com/house-energy-commerce-pushes-through-pbm-payment-reforms-biosimilar-access-legislation-ahead-of-new-year 2023-12-08 weekly 0.9 https://staging.previsionpolicy.com/national-hepatitis-c-subscription-treatment-plan-could-launch-in-2024-white-house-advisor-collins-says-timeline-hinges-on-cbo-score-collins-confident-gilead-and-abbvie-will-participate 2023-12-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-sickle-cell-tandem-approvals-bluebird-bio-vertex-crispr-treatments-cleared-simultaneously-but-price-and-labeling-differences-stand-out 2023-12-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-genetic-metabolic-diseases-advisory-committee-will-be-new-panel 2023-12-12 weekly 0.9 https://staging.previsionpolicy.com/fda-s-overseas-inspector-vacancies-need-innovative-solutions-house-leadership-says-unannounced-visits-in-china-still-delayed 2024-02-07 weekly 0.9 https://staging.previsionpolicy.com/sickle-cell-tandem-approvals-for-vertex-casgevy-bluebird-s-lyfgenia-timing-downplays-differences-but-regulatory-and-commercial-distinctions-have-broad-implications-for-gene-editing-gene-therapy 2023-12-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-opioid-approval-standard-would-be-raised-non-opioid-chronic-pain-guidance-demanded 2023-12-13 weekly 0.9 https://staging.previsionpolicy.com/pazdur-as-book-critic-big-sponsor-small-sponsor-differences-are-clear-to-fda-oncology-team-director-declares-in-discussion-with-biotech-author 2023-12-13 weekly 0.9 https://staging.previsionpolicy.com/fda-office-of-inspections-investigations-re-org-plan-finalized-pending-hhs-omb-clearance-restructuring-would-expand-role-of-cmo-create-new-office-of-enterprise-transformation 2023-12-13 weekly 0.9 https://staging.previsionpolicy.com/valneva-ixchiq-chikungunya-vaccine-showcases-fda-use-of-accelerated-approval-and-non-covid-vaccine-work-during-pandemic-pragmatic-confirmatory-trial-is-key-factor-in-decision 2023-12-13 weekly 0.9 https://staging.previsionpolicy.com/drug-drug-interactions-future-fda-guidance-will-focus-on-specific-modalities-patient-targeted-ddi-website-under-development 2023-12-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-updates-ira-medicare-inflation-rebate-guidances-to-clarify-relief-for-drugs-in-shortage 2023-12-14 weekly 0.9 https://staging.previsionpolicy.com/fda-advanced-manufacturing-technology-designation-guidance-uses-broad-criteria-for-novel-technology-will-cber-s-catt-help-amt-program-purr 2023-12-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-formalizes-withdrawal-of-abbvie-j-j-imbruvica-mcl-mzl-indications-odac-threat 2023-12-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-part-b-inflation-rebates-59-different-drugs-owe-rebates-in-first-year 2023-12-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-industry-face-to-face-meetings-will-expand-to-all-meeting-types-under-pdufa-bsufa-and-omufa-starting-january-22 2023-12-19 weekly 0.9 https://staging.previsionpolicy.com/adult-adhd-drug-development-fda-awaiting-clinical-guidelines-as-key-milestone-seeks-balance-to-ensure-appropriate-diagnosis-amid-shortages-abuse-potential 2023-12-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-manufacturer-quantity-reports-fda-finalizes-guidance-for-submissions-of-production-amounts-but-delays-effective-date 2024-02-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-reissues-covid-mab-development-guidance-to-support-ongoing-euas 2023-12-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-bespoke-gene-therapy-development-playbook-released-by-fnih 2024-02-07 weekly 0.9 https://staging.previsionpolicy.com/medicare-inflation-rebates-cms-will-give-30-days-to-suggest-errors-in-first-rounds-of-invoices-revised-guidance-provides-only-limited-relief-for-most-drugs-in-shortage 2023-12-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-randomized-umbrella-and-platform-trials-are-main-focus-of-fda-master-protocols-draft-guidance 2023-12-21 weekly 0.9 https://staging.previsionpolicy.com/real-world-evidence-policy-taking-shape-fda-finalizes-two-more-rwe-rwd-documents-along-with-digital-health-tools-guidance-as-2023-draws-to-a-close 2023-12-21 weekly 0.9 https://staging.previsionpolicy.com/cell-gene-therapy-products-take-center-stage-in-kick-off-of-cms-new-technology-payment-cycle-new-rules-on-fda-status-reduce-number-of-candidates-for-fy25-ntap-town-hall 2023-12-22 weekly 0.9 https://staging.previsionpolicy.com/fda-advisory-committee-trends-2023-a-tale-two-halves-fast-start-crashes-to-halt-uncertain-outlook-heading-into-2024 2024-01-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ctti-fda-report-recommends-strategies-for-improving-registration-and-reporting-of-clinical-trial-summary-results 2024-01-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-glp-1-safety-review-fda-sees-no-evidence-of-causal-link-for-suicidality-but-is-continuing-to-look-into-this-issue 2024-01-12 weekly 0.9 https://staging.previsionpolicy.com/generic-drug-reconsideration-process-updated-for-gdufa-iii-new-guidance-encourages-sponsors-to-use-post-crl-meetings-before-seeking-reconsideration 2024-01-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-office-of-compliance-fy23-annual-report 2024-01-16 weekly 0.9 https://staging.previsionpolicy.com/humira-biosimilar-uptake-in-part-d-will-be-watched-by-medpac-benefit-changes-in-2025-may-help-drive-adoption-staff-tells-commission 2024-01-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-updates-shutdown-contingency-plan-74-of-staff-would-be-retained 2024-01-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-commissioner-califf-says-gene-editing-biggest-new-thing-to-work-out-underscores-agency-officials-are-real-time-referees-on-aa 2024-01-18 weekly 0.9 https://staging.previsionpolicy.com/merck-sotatercept-pah-treatment-being-watched-for-price-impact-on-other-orphans-dec-1-icer-meeting-confirms-clinical-benefits-launch-price-concerns 2023-12-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-rare-disease-drug-development-guidance-finalized-by-fda-revisions-include-discussion-of-patient-input 2023-12-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-happy-new-year-17-days-until-next-fda-shutdown-deadline 2024-01-02 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-the-lull-continues-into-2024 2024-01-02 weekly 0.9 https://staging.previsionpolicy.com/direct-to-final-guidances-may-increase-under-fda-plan-to-enhance-advice-process-congressionally-mandated-report-notes-increase-in-guidance-output-over-past-decade 2024-01-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-geron-s-imetelstat-for-myelodysplastic-syndrome-to-get-icer-review-in-july 2024-01-03 weekly 0.9 https://staging.previsionpolicy.com/fda-s-advice-for-avoiding-clinical-holds-in-gene-cell-therapy-development-pay-attention-early-to-potency-assurance 2024-01-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-s-casgevy-crispr-sickle-cell-gene-therapy-approval-included-four-pre-license-inspections 2024-01-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-florida-rx-importation-plan-authorized-by-fda-approval-lasts-for-two-years 2024-01-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-funded-through-march-1-under-latest-continuing-resolution-passed-by-congress-january-18 2024-01-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-commissioner-califf-cber-director-peter-marks-discuss-vaccine-misinformation 2024-01-08 weekly 0.9 https://staging.previsionpolicy.com/fda-master-protocols-guidance-updates-covid-focused-advice-on-design-considerations-trial-integrity-a-key-concern 2024-01-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-orphan-drug-label-expansion-analysis 2024-01-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-office-of-regulatory-policy-acting-director-will-be-carol-bennett-elizabeth-jungman-named-chief-of-staff 2024-01-10 weekly 0.9 https://staging.previsionpolicy.com/fda-oncology-diagnostics-pilot-is-an-interim-step-to-fill-valid-void-but-stuck-in-neutral-as-agency-waits-to-sign-up-sponsors 2024-02-05 weekly 0.9 https://staging.previsionpolicy.com/florida-rx-import-plan-approved-by-fda-but-timing-and-impact-remain-uncertain-will-first-sip-lead-to-bigger-gulps 2024-02-07 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-car-t-reviews-highlight-upcoming-agenda-as-lull-comes-to-an-end 2024-03-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-prolia-gets-boxed-warning-for-increased-risk-of-severe-hypocalcemia 2024-01-22 weekly 0.9 https://staging.previsionpolicy.com/fda-revamp-of-ora-will-resolve-inspection-issues-more-quickly-agency-says-manufacturers-will-need-to-learn-new-contacts 2024-01-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-car-t-safety-label-update-secondary-malignancy-risk-will-be-added-to-black-box-for-all-agents-gilead-s-tecartus-stands-out 2024-01-23 weekly 0.9 https://staging.previsionpolicy.com/mie-time-fda-urging-participation-in-generic-drugs-model-integrated-evidence-meeting-pilot-says-modeling-will-be-essential-for-future-of-generic-development 2024-01-23 weekly 0.9 https://staging.previsionpolicy.com/gene-therapy-in-2024-fda-s-marks-wants-a-breakout-year-though-ramp-up-may-take-longer 2024-01-10 weekly 0.9 https://staging.previsionpolicy.com/car-t-safety-cber-s-marks-calms-the-waters-after-malignancy-alert-but-fda-likely-to-want-more-monitoring-in-non-oncology-setting 2024-01-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-another-car-t-sbla-advisory-committee-j-j-legend-s-carvykti-will-go-to-odac-for-label-expansion 2024-01-24 weekly 0.9 https://staging.previsionpolicy.com/ai-neuroscience-tool-for-depression-accepted-by-fda-into-istand-program-milestone-in-rapidly-advancing-field-but-still-long-process-ahead 2024-01-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-updates-remote-regulatory-assessment-q-a-guidance-fdora-provisions 2024-01-25 weekly 0.9 https://staging.previsionpolicy.com/nme-approvals-in-2023-back-to-near-historic-highs-but-some-signs-of-covid-fatigue-may-be-showing-up-at-fda 2024-01-10 weekly 0.9 https://staging.previsionpolicy.com/senate-finance-drug-shortages-white-paper-focuses-on-generic-injectable-payment-in-medicare-outpatient-drug-ideas-including-medicaid-rebate-changes-appear-farther-away 2024-01-25 weekly 0.9 https://staging.previsionpolicy.com/pre-term-birth-drug-development-after-makena-new-endpoints-await-better-understanding-of-etiology-modeling-approaches-may-help 2024-01-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biopharma-congress-is-only-one-month-away-cber-s-peter-marks-and-celia-witten-oce-s-richard-pazdur-and-janet-woodcock 2024-01-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-odac-to-review-geron-s-imetelstat-for-mds-on-march-14 2024-01-29 weekly 0.9 https://staging.previsionpolicy.com/fda-revises-race-and-ethnicity-data-collection-guidance-but-demographic-rule-review-may-lead-to-future-changes-diversity-action-plans-fall-outside-of-scope 2024-01-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-plans-cell-and-gene-therapy-faq-draft-guidance-for-2024-publication-quick-turnaround-anticipated-for-potency-assurance-guidance 2024-01-30 weekly 0.9 https://staging.previsionpolicy.com/remote-regulatory-assessments-fda-updates-draft-guidance-to-incorporate-fdora-authorities-for-remote-inspections-friendlier-tone-encouraging-firms-to-participate-when-rras-are-voluntary 2024-01-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biogen-to-discontinue-aduhelm-landmark-and-contentious-approval-ends-with-a-whimper 2024-01-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-advisory-committee-revamp-still-under-internal-debate-but-fda-already-getting-better-experts 2024-02-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-s-vrbpac-to-review-flu-strains-for-vaccines-on-march-5 2024-02-08 weekly 0.9 https://staging.previsionpolicy.com/340b-at-a-critical-inflection-point-hrsa-s-pedley-says-but-congress-hrsa-unlikely-to-clarify-scope-of-eligibility-for-discounts-or-resolve-contract-pharmacy-rules-any-time-soon 2024-02-01 weekly 0.9 https://staging.previsionpolicy.com/awkward-allies-on-medicare-price-negotiation-340b-providers-could-face-significant-loss-once-ira-price-cuts-are-implemented 2024-02-01 weekly 0.9 https://staging.previsionpolicy.com/the-war-on-drug-shortages-onshoring-push-would-start-with-battlefield-medicines-under-house-bill-discussed-during-ways-means-hearing-buffer-stocks-also-have-support 2024-02-08 weekly 0.9 https://staging.previsionpolicy.com/manufacturer-quantity-report-guidance-finalized-2023-data-due-in-august-fda-says-older-reports-should-be-submitted-as-soon-as-possible-and-all-will-be-kept-confidential 2024-02-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-sets-march-15-date-for-abecma-carvykti-sbla-adcomm-general-discussion-focused-on-the-overall-survival-data 2024-02-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-valneva-sells-priority-review-voucher-for-103-million 2024-02-06 weekly 0.9 https://staging.previsionpolicy.com/cder-plans-ai-in-drug-development-guidance-for-2024-new-rwe-guidance-added-to-regulatory-agenda 2024-02-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-oce-reunion-panel-at-biopharma-congress-feb-26-has-director-rick-pazdur-moderating 2024-02-13 weekly 0.9 https://staging.previsionpolicy.com/senate-show-trial-on-drug-pricing-allows-ceos-to-pitch-co-pay-and-contracting-reform-agenda-medicare-negotiation-hangs-over-event-but-details-not-discussed 2024-02-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-diversity-action-plans-guidance-fda-actively-working-on-draft 2024-02-09 weekly 0.9 https://staging.previsionpolicy.com/adaptation-committee-suggested-by-fda-as-tool-for-adaptive-trial-oversight-in-proposed-update-to-2006-guidance-on-data-monitoring-committees 2024-02-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-finalizes-updated-guidance-on-charging-for-investigational-drugs 2024-02-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-the-new-accelerated-approval-withdrawal-process-stay-tuned-in-coming-weeks-fda-s-marks 2024-02-15 weekly 0.9 https://staging.previsionpolicy.com/wholesaler-gpo-role-in-drug-shortages-is-new-focus-for-hhs-ftc-competition-initiative-rfi-asks-about-impact-of-consolidation-contracting-on-supply-chain 2024-02-15 weekly 0.9 https://staging.previsionpolicy.com/cber-readying-for-next-covid-vaccine-strain-selection-director-marks-says-during-house-hearing-on-vaccine-safety-systems 2024-02-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-part-d-co-pay-smoothing-cms-releases-second-implementation-guidance-focusing-on-pharmacy-outreach 2024-02-16 weekly 0.9 https://staging.previsionpolicy.com/artificial-intelligence-getting-cross-center-attention-at-fda-with-ai-guidance-among-activities-under-white-house-executive-order-can-trials-move-from-reactive-to-predictive 2024-02-19 weekly 0.9 https://staging.previsionpolicy.com/implementing-project-optimus-oncology-dose-optimization-can-learn-from-other-areas-but-cancer-will-still-be-different-aacr-workshop-drills-down-on-approaches 2024-02-16 weekly 0.9 https://staging.previsionpolicy.com/psychedelics-are-sizeable-chunk-of-fda-division-of-psychiatry-workload-teasing-out-role-and-effect-of-psychotherapy-in-psychedelic-treatment-paradigm-is-a-key-issue 2024-02-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-iovance-amtagvi-lifileucel-melanoma-approval-is-first-tumor-derived-t-cell-immunotherapy 2024-02-20 weekly 0.9 https://staging.previsionpolicy.com/building-quality-by-design-in-clinical-trials-starts-with-predicting-what-can-go-wrong-fda-s-stein-says-natural-history-diversity-key-factors-in-rare-diseases 2024-02-19 weekly 0.9 https://staging.previsionpolicy.com/cms-sickle-cell-gene-therapy-access-model-creates-18-month-period-for-bluebird-vertex-and-state-medicaid-programs-to-work-out-rebate-agreements 2024-02-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-updates-covid-therapeutics-development-guidance-new-version 2024-02-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biopharma-congress-is-sold-out 2024-02-22 weekly 0.9 https://staging.previsionpolicy.com/gene-therapy-international-cooperation-fda-hopes-simultaneous-reviews-by-key-regulatory-bodies-will-make-some-rare-disease-markets-more-viable 2024-02-25 weekly 0.9 https://staging.previsionpolicy.com/diversity-action-plan-guidance-delayed-as-fda-works-to-provide-more-information-otp-s-fashoyin-aje-says-fda-interprets-diversity-very-broadly 2024-02-25 weekly 0.9 https://staging.previsionpolicy.com/bespoke-gene-therapy-consortium-playbook-for-aav-gene-therapy-development-published-platform-approach-could-be-model-for-new-pathway 2024-02-27 weekly 0.9 https://staging.previsionpolicy.com/icer-review-of-novartis-and-astrazeneca-pnh-therapies-patient-adherence-will-be-critical-issue-for-uptake-of-novel-oral-treatments-panel-says 2024-02-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-approved-90-first-generics-in-2023-office-of-generic-drugs-annual-report 2024-02-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-merck-winrevair-sotatercept-approval-opens-potential-for-patient-at-home-administration 2024-03-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-c-path-launches-dmd-clinical-trial-simulator 2024-03-29 weekly 0.9 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https://staging.previsionpolicy.com/pepaxto-withdrawal-indicates-fdora-has-improved-the-process-for-pulling-accelerated-approval-but-not-solved-all-fda-s-problems 2024-02-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-manufacturing-user-fees-floated-by-woodcock-to-better-fund-inspections 2024-02-28 weekly 0.9 https://staging.previsionpolicy.com/fda-s-gene-cell-therapy-office-ramp-up-will-take-2-3-years-cber-s-marks-predicts-will-2027-be-a-milestone-year-for-rare-disease-organization-at-fda 2024-02-28 weekly 0.9 https://staging.previsionpolicy.com/we-re-coming-back-most-advisory-committees-will-be-in-person-this-fall-changes-in-recruitment-are-underway-but-the-votes-will-stay 2024-02-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-informed-consent-key-information-draft-guidance-includes-template 2024-02-29 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-medicare-part-d-co-pay-smoothing-option-will-be-offered-to-any-beneficiary-with-co-pay-of-600 2024-03-01 weekly 0.9 https://staging.previsionpolicy.com/rtor-tracker-fda-oncology-real-time-review-approval-pace-lags-from-2021-peak-first-known-rejection-in-2024 2024-07-29 weekly 0.9 https://staging.previsionpolicy.com/hhs-inter-agency-real-world-data-registry-collaboration-underway-nih-looking-separately-to-collaborate-with-fda-in-the-post-market 2024-04-18 weekly 0.9 https://staging.previsionpolicy.com/rwe-efforts-need-better-data-standards-and-quality-no-matter-the-regulatory-intent-oce-s-kluetz-says-case-studies-show-even-failed-attempts-have-benefits 2024-03-01 weekly 0.9 https://staging.previsionpolicy.com/orphan-drug-price-negotiation-fixes-remain-a-partisan-issue-during-house-hearing-democrats-also-raise-issues-with-rare-disease-prv-reauthorization 2024-03-01 weekly 0.9 https://staging.previsionpolicy.com/gene-edited-products-drug-sponsors-should-strongly-consider-accelerated-approval-fda-reviewers-say-off-target-safety-still-a-concern 2024-03-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ldt-final-rule-goes-to-omb-for-review-on-march-1 2024-03-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-vanda-hetlioz-jet-lag-indication-laid-to-rest-fda-denies-another-request 2024-03-05 weekly 0.9 https://staging.previsionpolicy.com/cder-quantitative-medicine-coe-is-example-of-structural-change-to-foster-regulatory-innovation-time-to-stop-the-pilots-director-cavazzoni-says 2024-03-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lumicell-s-lumisight-breast-cancer-imaging-agent-clears-fda-advisory-committee-with-16-2-vote 2024-03-06 weekly 0.9 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2024-05-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lilly-donanemab-alzheimer-treatment-gets-strong-efficacy-and-benefit-risk-endorsement 2024-06-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lilly-donanemab-committee-review-will-involve-two-members-with-coi-waivers 2024-05-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-office-of-inspections-investigations-receives-final-approval-ahead-of-october-1 2024-05-31 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-machine-learning-for-shortage-prediction 2024-05-17 weekly 0.9 https://staging.previsionpolicy.com/fda-neurology-office-very-open-to-accelerated-approval-director-buracchio-says-cber-officials-see-more-intermediate-endpoints-for-underutilized-aa-pathway 2024-05-17 weekly 0.9 https://staging.previsionpolicy.com/lykos-mdma-for-ptsd-two-positive-trials-but-large-unblinding-impact-abuse-potential-is-real-though-fda-appears-open-to-approval-with-very-tight-rems 2024-05-31 weekly 0.9 https://staging.previsionpolicy.com/rare-pediatric-disease-prv-reauthorization-may-come-with-strings-attached-new-authority-for-fda-to-mandate-pediatric-studies-of-orphan-drugs 2024-05-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-judiciary-pharmaceutical-competition-hearing-will-include-phrma-vp-ulrich-patient-advocate-mitchell 2024-05-20 weekly 0.9 https://staging.previsionpolicy.com/project-orbis-update-fda-nearing-100-approvals-under-global-oncology-collaboration-japan-ema-and-india-are-focus-of-oce-outreach-efforts 2024-05-20 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-access-plans-potentially-including-pricing-commitments-will-be-part-of-nih-technology-transfer-agreements 2024-05-22 weekly 0.9 https://staging.previsionpolicy.com/regulatory-flexibility-for-rare-diseases-ex-fdaer-woodcock-endorses-new-legislative-pathway-cber-s-marks-favors-working-under-existing-regs 2024-05-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biosecure-act-path-to-enactment-looks-less-secure 2024-06-12 weekly 0.9 https://staging.previsionpolicy.com/senate-drug-shortage-bill-would-create-medicare-shortage-mitigation-program-generic-medicaid-inflation-rebate-changes-add-on-payments-included 2024-05-23 weekly 0.9 https://staging.previsionpolicy.com/cder-cber-rare-disease-innovation-agenda-will-align-regulatory-efforts-under-shared-vision-fda-center-directors-say-at-house-hearing 2024-05-23 weekly 0.9 https://staging.previsionpolicy.com/novo-s-once-weekly-insulin-icodec-for-type-1-diabetes-voted-down-by-fda-panel-due-to-hypoglycemia-risk-little-appetite-for-risk-management-but-type-2-use-assured 2024-05-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-platform-technology-designation-program-draft-guidance-released-fda-estimates-10-requests-per-year 2024-05-28 weekly 0.9 https://staging.previsionpolicy.com/diversity-action-plan-guidance-fda-wants-daps-by-end-of-phase-ii-meeting-says-waivers-will-be-rare-requirement-on-track-to-kick-in-for-2026 2024-06-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ultragenyx-will-file-sanfilippo-syndrome-gene-therapy-application-for-accelerated-approval 2024-06-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicare-weight-loss-drug-coverage-bill-heads-to-mark-up-june-27-modified-house-bill 2024-06-27 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-cder-artificial-intelligence-policy-lead-is-tala-fakhouri 2024-06-17 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-astrazeneca-imfinzi-sbla-will-test-fda-s-how-much-is-enough-concerns-at-odac-committee-meetings-still-lagging-in-2024 2024-06-28 weekly 0.9 https://staging.previsionpolicy.com/lilly-s-donanemab-positive-fda-panel-paves-way-to-early-alzheimer-s-treatments-tau-staging-not-a-prerequisite 2024-06-18 weekly 0.9 https://staging.previsionpolicy.com/healthy-disagreement-fda-s-califf-highlights-value-of-public-debate-as-key-to-advisory-committee-reform-push-timeline-for-changes-still-unclear 2024-06-17 weekly 0.9 https://staging.previsionpolicy.com/cmmi-accelerated-approval-model-may-not-advance-as-fast-as-initially-proposed-sickle-cell-disease-model-has-received-letters-of-intent-from-states-covering-80-of-scd-patients 2024-06-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hhs-oig-allows-financial-assistance-for-sickle-cell-gene-therapy-in-june-17-opinion-travel-lodging-meals-and-associated-expenses 2024-06-18 weekly 0.9 https://staging.previsionpolicy.com/340b-house-gop-bill-defines-patient-and-requires-pass-through-of-discounts-subcommittee-hearing-features-bipartisan-interest-in-fixes-but-further-action-is-tbd 2024-06-18 weekly 0.9 https://staging.previsionpolicy.com/fda-after-chevron-immediate-changes-unlikely-more-litigation-and-fewer-regs-may-follow-cms-pricing-policies-may-have-bigger-impacts 2024-07-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-interchangeable-biosimilar-guidance-update-fda-says-switching-study-standards-have-evolved 2024-06-20 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-listening-session-industry-mostly-sits-out-fda-feedback-meeting-abbvie-registers-preference-for-separate-documents-elevated-patient-voice 2024-06-20 weekly 0.9 https://staging.previsionpolicy.com/interchangeable-for-all-switching-studies-may-be-unnecessary-for-interchangeable-biosimilar-designations-fda-says-in-draft-guidance 2024-06-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-sarepta-dmd-gene-therapy-label-expansion-cber-director-marks-again-overrules-staff 2024-06-21 weekly 0.9 https://staging.previsionpolicy.com/n-of-1-cber-s-marks-again-overrules-staff-in-granting-sarepta-dmd-gene-therapy-label-expansion-one-last-regulatory-checkpoint-due-in-2027-with-envision-trial 2024-06-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ldt-small-entity-compliance-guide-issued-by-fda 2024-06-24 weekly 0.9 https://staging.previsionpolicy.com/rwe-only-to-support-a-new-indication-yes-potentially-fda-s-concato-says 2024-06-24 weekly 0.9 https://staging.previsionpolicy.com/fda-rare-disease-innovation-hub-is-born-out-of-cross-center-agenda-cber-s-marks-is-taking-the-lead-with-communication-an-initial-focus 2024-06-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-another-supreme-court-ruling-will-impact-fda-regulation-statute-of-limitations-decision 2024-07-02 weekly 0.9 https://staging.previsionpolicy.com/fda-aims-to-streamline-drug-delivery-device-development-in-new-guidance-detailing-process-for-establishing-essential-drug-delivery-outputs-eddos 2024-07-02 weekly 0.9 https://staging.previsionpolicy.com/sickle-cell-gene-therapy-model-states-will-need-to-provide-assurance-of-access-to-participate-in-cmmi-demo-streamlining-emphasized-over-pricing-in-rfa 2024-07-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lilly-kisunla-donanemab-clears-fda-for-alzheimer-s-early-dosing-cutoff 2024-07-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-post-marketing-surveillance-with-real-world-data-fda-opens-comment-period-on-ich-guidance 2024-07-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-misinformation-guidance-tailored-responsive-communications-is-new-category-of-sponsor-communication 2024-07-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cisplatin-shortage-resolved-fda-reports-june-27 2024-07-08 weekly 0.9 https://staging.previsionpolicy.com/cber-guidances-on-rare-disease-gene-therapy-accelerated-approval-crispr-as-platform-added-to-2024-agenda 2024-07-08 weekly 0.9 https://staging.previsionpolicy.com/cancer-drug-tolerability-fda-developing-framework-for-symptom-selection-to-support-pro-collection-by-sponsors 2024-07-08 weekly 0.9 https://staging.previsionpolicy.com/fda-misinformation-guidance-tailored-responsive-communications-would-have-safe-harbor-under-new-draft-greater-ability-for-firms-to-respond-online 2024-07-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-zevra-arimoclomol-resubmission-will-be-first-review-by-fda-genetic-metabolic-diseases-advisory-committee 2024-07-09 weekly 0.9 https://staging.previsionpolicy.com/ftc-interim-report-on-pbms-includes-call-for-further-attention-to-exclusionary-rebates-that-block-generics-biosimilars-are-pbms-too-big-to-understand 2024-07-09 weekly 0.9 https://staging.previsionpolicy.com/drug-device-combos-fda-use-related-risk-analysis-guidance-fleshes-out-agency-s-thinking-on-best-approaches-to-urras-as-guide-for-human-factor-studies 2024-07-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-big-three-pbms-reportedly-to-testify-at-house-oversight-committee-hearing-july-23 2024-07-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biosecure-act-path-to-enactment-taking-shape-senate-may-attach-house-version-to-defense 2024-07-12 weekly 0.9 https://staging.previsionpolicy.com/medicare-inflation-rebate-reconciliation-process-added-in-regulatory-codification-cms-proposes-to-estimate-340b-units-for-part-d-rebate-exclusion 2024-07-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-fda-appropriations-bill-gives-fda-22-million-increase 2024-07-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-partial-onset-seizure-therapeutics-fda-revises-guidance-to-include-efficacy-extrapolation-from-adults-to-infants 2024-07-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-extends-platform-technology-designation-guidance-comment-period-to-aug-28 2024-07-16 weekly 0.9 https://staging.previsionpolicy.com/cder-artificial-intelligence-council-will-catalogue-coordinate-ai-activities-in-the-center-another-structural-move-to-address-emerging-field 2024-08-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-preparing-to-expand-integrated-review-template-to-more-applications-wants-feedback 2024-09-06 weekly 0.9 https://staging.previsionpolicy.com/fda-appropriations-bills-point-towards-flat-funding-house-and-senate-committees-show-interest-in-accelerated-approval-dea-scheduling-psychedelics-and-drug-shortages 2024-07-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-genetic-metabolic-diseases-advisory-committee-fda-announces-first-four-members 2024-07-17 weekly 0.9 https://staging.previsionpolicy.com/gemdac-starts-small-four-members-named-to-fda-s-newest-advisory-committee-ahead-of-inaugural-meeting-six-vacancies-remain 2024-07-17 weekly 0.9 https://staging.previsionpolicy.com/fda-approval-decisions-may-face-legal-challenges-post-chevron-but-not-in-the-near-term-legal-analysts-suggest 2024-07-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-formally-unveils-rare-disease-innovation-hub-cder-seeks-new-associate-director-for-rare-disease-strategy 2024-07-18 weekly 0.9 https://staging.previsionpolicy.com/fda-vaccine-office-after-covid-low-profile-experienced-leaders-underlie-high-profile-approvals 2024-08-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-vaccines-office-deputy-is-karin-bok 2024-09-03 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-updates-nitrosamine-guidance-to-set-august-1-deadline-for-ndsri-testing 2024-09-04 weekly 0.9 https://staging.previsionpolicy.com/working-toward-an-fda-rare-disease-center-hub-locks-in-compromise-approach-for-now 2024-07-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ardelyx-sues-cms-to-block-xphozah-payment-change 2024-07-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-declines-to-set-expiration-date-on-coverage-with-evidence-development 2024-08-08 weekly 0.9 https://staging.previsionpolicy.com/oce-s-lucky-seven-years-oncology-reviewers-reflect-on-center-s-success-name-assessment-aid-and-project-facilitate-as-favorite-programs 2024-07-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-democratic-campaign-shakeup-means-new-president-will-appoint-next-fda-commissioner 2024-07-22 weekly 0.9 https://staging.previsionpolicy.com/fda-biosimilar-post-approval-changes-draft-guidance-includes-path-for-dose-formulation-supplements 2024-07-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-oversight-committee-releases-pbm-report-ahead-of-july-23-hearing 2024-07-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-rare-disease-hub-priorities-are-the-focus-of-oct-16-in-person-workshop 2024-08-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lykos-to-request-an-fda-meeting-for-a-reconsideration-of-the-decision-to-reject-the-mdma-therapy-will-pursue-all-available-regulatory-pathways 2024-08-12 weekly 0.9 https://staging.previsionpolicy.com/astrazeneca-s-imfinzi-for-nsclc-odac-likely-to-recommend-approval-after-wading-through-aegean-but-future-perioperative-applications-will-require-new-trial-designs 2024-07-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-appropriations-white-house-says-it-would-veto-house-version 2024-07-24 weekly 0.9 https://staging.previsionpolicy.com/randomized-trials-are-preferrable-in-non-muscle-invasive-bladder-cancer-updated-fda-guidance-says-bcg-shortage-addressed-in-revision 2024-08-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-stealth-bio-elamipretide-for-barth-syndrome-set-for-cardio-renal-advisory-committee-review-october-10 2024-09-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-i-worked-very-hard-on-that-former-president-donald-trump-says-of-fda-drug-review-times 2024-08-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-arpa-h-real-world-data-request-for-information 2024-07-25 weekly 0.9 https://staging.previsionpolicy.com/type-d-meetings-are-taking-off-at-fda-though-scope-of-questions-can-be-an-issue-virtual-meetings-are-generally-popular-with-sponsors 2024-07-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-science-board-to-meet-october-7-to-discuss-agency-reorganizations-reducing-animal-testing 2024-08-14 weekly 0.9 https://staging.previsionpolicy.com/vp-kamala-harris-marches-in-to-presidential-campaign-could-march-in-on-drug-prices-if-elected 2024-07-25 weekly 0.9 https://staging.previsionpolicy.com/fda-eager-to-interact-with-start-ups-webinar-emphasizes-range-of-meeting-opportunities-enthusiasm-of-agency-to-engage 2024-09-05 weekly 0.9 https://staging.previsionpolicy.com/cdrh-director-transition-will-have-tarver-overseeing-early-implementation-of-ldt-rule-will-other-center-directors-leave-in-2025 2024-07-25 weekly 0.9 https://staging.previsionpolicy.com/az-imfinzi-on-track-for-broad-label-in-early-stage-lung-cancer-but-door-is-closing-for-peri-operative-claims-without-bigger-trials 2024-07-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hhs-acting-chief-ai-officer-will-be-micky-tripathi 2024-07-26 weekly 0.9 https://staging.previsionpolicy.com/house-pbm-reform-hearing-points-to-renewed-legislative-push-in-2025-busting-up-the-big-three-could-be-a-theme 2024-07-26 weekly 0.9 https://staging.previsionpolicy.com/ai-for-real-world-data-generation-fda-highlights-risk-based-approach-to-adoption-for-regulatory-applications 2024-07-26 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-medicare-drug-price-cuts-all-over-50-except-for-one-imbruvica-in-the-inaugural-class-of-10-part-d-drugs 2024-08-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-vp-kamala-harris-applauds-bold-cms-administrator-brooks-lasure-highlights-role-in-passing-ira 2024-08-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicare-negotiated-prices-will-be-announced-soon-cms-deputy 2024-08-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-harris-administration-would-accelerate-the-speed-of-medicare-negotiations-for-rx-drugs 2024-08-19 weekly 0.9 https://staging.previsionpolicy.com/cms-declares-importance-of-observational-rwe-studies-to-ced-upcoming-fit-for-purpose-guidance-will-define-acceptable-studies 2024-08-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biosecure-act-set-to-pass-house-during-china-week 2024-09-09 weekly 0.9 https://staging.previsionpolicy.com/generic-drug-sponsors-may-discuss-alternative-approaches-to-be-requirements-during-pre-anda-meetings-in-finalized-guidance-teva-requested-change 2024-08-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-project-orbis-approval-johnson-johnson-s-sbla-for-lazcluze-lazertinib-gets-fda-approval 2024-08-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-happy-halloween-sotagliflozin-heads-to-fda-advisory-committee-october-31-in-next-stop-of-tortured-regulatory-history 2024-08-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-odac-pd-l1-reviews-set-for-september-26-in-gastric-esophageal-cancers 2024-08-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-adaptimmune-tecelra-accelerated-approval-short-confirmatory-trial-plan 2024-08-05 weekly 0.9 https://staging.previsionpolicy.com/medicare-inpatient-sickle-cell-gene-therapy-enhanced-payments-will-total-nearly-300-million-in-fiscal-2025-cms-estimates-six-new-drugs-gain-ntap-status 2024-08-05 weekly 0.9 https://staging.previsionpolicy.com/zevra-s-arimoclomol-clears-fda-advisory-committee-in-niemann-pick-gemdac-endorses-small-but-consistent-efficacy-in-inaugural-meeting 2024-08-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lykos-mdma-nda-fda-decision-watched-by-bipartisan-group-of-senators 2024-08-06 weekly 0.9 https://staging.previsionpolicy.com/harris-vp-pick-walz-pushed-drug-pricing-transparency-policies-capping-insulin-co-pays-pdab-also-on-minnesota-governor-s-progressive-agenda 2024-08-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-draft-guidance-on-use-of-ai-in-drug-biological-development-coming-soon 2024-08-07 weekly 0.9 https://staging.previsionpolicy.com/fda-ai-policy-clarity-will-foster-innovation-cder-s-cavazzoni-says-context-of-use-will-be-key-consideration-for-risk-based-approach-in-upcoming-guidance 2024-08-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biosecure-clears-house-september-9-79-democrats-vote-no 2024-09-10 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-rare-neurodegenerative-disease-grant-program-looking-for-innovative-trial-designs 2024-08-23 weekly 0.9 https://staging.previsionpolicy.com/schizophrenia-drug-development-fda-urges-importance-of-studying-negative-symptoms-in-clinical-trials-farchione-rethinks-early-advice-on-phase-iii-design 2024-08-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-340b-rebate-j-j-tells-dsh-hospitals-that-stelara-and-xarelto-340b-prices 2024-08-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-patient-friendly-informed-consent-will-be-focus-of-fda-patient-engagement-advisory-committee-meeting-october-30 2024-08-27 weekly 0.9 https://staging.previsionpolicy.com/cder-quantitative-medicine-center-of-excellence-plans-repository-of-case-studies-mission-emphasizes-education-about-qm-successes 2024-09-10 weekly 0.9 https://staging.previsionpolicy.com/bla-facility-related-rejections-increasing-within-cder-fda-urges-increased-communication-china-backlog-cleared-but-challenges-remain 2024-09-05 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-they-re-back-in-person-meetings-resume-and-fda-has-plenty-on-tap-odac-will-look-at-another-pd-1-labeling-issue 2024-10-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-help-committee-chair-bernie-sanders-highlights-lilly-announcement-to-lower-zepbound-starter-dose-list-price 2024-08-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-oversight-chair-james-comer-r-ky-requests-hearing-testimony-correction-from-pbm-chief-executives 2024-08-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-vaccines-advisory-committee-will-discuss-considerations-for-avian-flu-vaccine-composition-at-october-10-meeting 2024-09-18 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-encourages-a-syn-biomarker-for-patient-selection-in-parkinson-s 2024-08-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-commissioner-califf-lauds-promise-of-omics-science-but-stresses-need-for-oversight 2024-09-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicare-drug-price-negotiation-is-briefly-mentioned-in-presidential-debate 2024-09-11 weekly 0.9 https://staging.previsionpolicy.com/iterum-s-oral-sulopenem-likely-to-receive-approval-in-restricted-uuti-population-following-favorable-advisory-committee-discussion 2024-09-11 weekly 0.9 https://staging.previsionpolicy.com/fda-advanced-manufacturing-strategy-final-amt-guidance-coming-soon-cber-catt-2-0-internal-procedures-under-revision-cder-etp-guidance-update-in-2026 2024-09-13 weekly 0.9 https://staging.previsionpolicy.com/cms-sets-the-negotiation-bar-60-off-list-price-appears-to-be-the-baseline-going-forward-diabetes-makes-up-four-of-top-five-cancer-drugs-may-feel-greatest-impact 2025-10-28 weekly 0.9 https://staging.previsionpolicy.com/rare-disease-innovation-hub-october-kick-off-meeting-will-solicit-input-on-specific-policy-priorities-engagement-practices-oce-to-be-involved 2024-09-05 weekly 0.9 https://staging.previsionpolicy.com/refuse-to-file-easily-correctable-problems-added-to-revised-cber-sopp-document-says-center-will-attempt-to-rectify-those-issues 2024-09-11 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-patent-reform-bill-votes-postponed-in-senate-judiciary-committee-chair-dick-durbin-d-ill-says 2024-09-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-pediatric-voucher-program-would-be-extended-to-december-20-under-continuing-resolution 2024-09-23 weekly 0.9 https://staging.previsionpolicy.com/medicaid-rebates-cms-drops-price-verification-rebate-stacking-proposals-misclassification-policy-finalized-along-with-other-technical-changes 2024-09-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-rare-pediatric-disease-priority-review-voucher-reauthorization-bill-passes-house 2024-09-24 weekly 0.9 https://staging.previsionpolicy.com/checkpoint-inhibitor-cut-points-odac-will-hear-case-for-biomarker-based-indications-esophageal-relabeling-may-be-more-likely-than-gi-merck-bristol-beigene-to-present 2024-09-24 weekly 0.9 https://staging.previsionpolicy.com/fda-oncology-office-cautions-sponsors-about-pitfalls-of-open-label-rcts-in-journal-article-lumakras-is-one-object-lesson 2024-09-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-aa-for-rare-disease-gene-therapies-guidance-will-offer-clear-expectations-on-data-required-to-support-endpoints 2024-09-25 weekly 0.9 https://staging.previsionpolicy.com/senate-help-chair-sanders-springs-pbm-surprise-on-novo-at-hearing-but-ceo-gives-strong-performance-under-pressure-international-reference-pricing-gets-cameo 2024-09-25 weekly 0.9 https://staging.previsionpolicy.com/rare-disease-project-proliferation-at-fda-agency-needs-to-focus-on-management-of-initiatives-national-academy-of-medicine-report-says 2024-10-17 weekly 0.9 https://staging.previsionpolicy.com/fda-rare-disease-hub-organization-builds-on-existing-review-divisions-within-cber-cder-stability-will-benefit-application-reviews-cber-s-tierney-says 2024-09-26 weekly 0.9 https://staging.previsionpolicy.com/pertussis-challenge-models-are-promising-fda-panel-agrees-but-may-not-be-ready-for-pivotal-efficacy-trials-increasing-vaccination-in-pregnancy-may-be-more-immediate-priority 2024-09-26 weekly 0.9 https://staging.previsionpolicy.com/medicare-rx-inflation-rebate-rule-finalized-but-340b-exclusion-still-unsettled-cms-working-on-claims-data-repository-that-could-help-for-negotiated-pricing-too 2024-11-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-expands-star-real-time-review-pilot-novel-applications-may-be-submitted-for-program-participation-dec-2 2024-11-05 weekly 0.9 https://staging.previsionpolicy.com/clozapine-rems-review-fda-committee-will-decide-if-program-can-be-pared-back-or-eliminated-given-experience-during-decade-of-enforcement-discretion 2024-11-15 weekly 0.9 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https://staging.previsionpolicy.com/rare-disease-hub-top-priority-should-be-consistent-review-standards-stakeholders-tell-fda-cber-s-marks-explains-why-full-center-of-excellence-not-pursued 2024-10-17 weekly 0.9 https://staging.previsionpolicy.com/merck-bristol-beigene-urged-to-support-biomarker-collaboration-by-oce-director-pazdur-during-odac-review-of-proposed-label-restrictions 2024-09-27 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-stealth-bio-barth-syndrome-resubmission-heads-to-panel-applied-sciences-galactosemia-nda-will-not-need-gemdac-after-all 2024-09-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-bristol-myers-cobenfy-schizophrenia-approval 2024-09-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hrsa-threatens-sanctions-on-j-j-over-proposed-340b-rebate-program 2024-09-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-gilead-to-withdraw-accelerated-approval-for-trodelvy-in-urothelial-cancer 2024-10-18 weekly 0.9 https://staging.previsionpolicy.com/accelerated-approval-in-oncology-15-withdrawal-rate-but-a-failed-confirmatory-trial-does-not-always-equate-to-a-failed-drug-fda-says 2024-10-18 weekly 0.9 https://staging.previsionpolicy.com/lexicon-sotagliflozin-for-t1-diabetes-haunted-by-dka-risk-in-fda-adcomm-halloween-sequel-panel-spooked-by-uncertainty-but-can-sota-be-resurrected 2024-11-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-ira-repeal-a-possibility-if-republicans-sweep-by-taking-the-house-following-trump-s-victory 2024-11-06 weekly 0.9 https://staging.previsionpolicy.com/fda-s-global-strategy-needs-to-be-revitalized-with-a-more-transparent-global-supply-chain-and-better-purchasing-behavior-from-drug-companies-califf-says 2024-09-30 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-maximum-fair-price-based-on-ex-us-pricing-would-reduce-rx-drug-prices-by-5-and-possibly-substantially-more-cbo-says 2024-10-07 weekly 0.9 https://staging.previsionpolicy.com/medicare-coverage-of-weight-loss-drugs-cbo-sees-slim-offsetting-savings-from-use-in-obese-overweight-population-10-year-federal-cost-pegged-at-35-billion 2024-10-09 weekly 0.9 https://staging.previsionpolicy.com/otc-contraceptive-coverage-policy-could-expand-to-smoking-cessation-products-if-proposed-rule-carries-forward-after-election-day 2024-10-21 weekly 0.9 https://staging.previsionpolicy.com/fda-antiemetic-draft-guidance-may-facilitate-registrational-trials-for-drugs-used-off-label-for-postoperative-nausea-vomiting-prophylaxis-agency-says 2024-10-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-prioritizing-regulatory-flexibility-under-rare-disease-program-cross-cutting-internal-teams 2024-10-22 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-rsv-vaccines-for-use-in-children-fda-vaccines-committee-will-discuss 2024-10-23 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-medicare-coverage-of-obesity-agents-would-cost-35-billion-through-2034-cbo-estimates 2024-10-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-trump-backing-off-of-most-favored-nation-rule-phrma-ceo-ubl-says-pbm-reform 2024-10-10 weekly 0.9 https://staging.previsionpolicy.com/stealth-bio-elamipretide-for-barth-syndrome-advisory-committee-is-last-chance-to-head-off-rejection-fda-says-data-do-not-support-efficacy 2024-10-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-15-year-follow-up-for-gene-therapies-challenged-as-mind-boggling 2024-10-11 weekly 0.9 https://staging.previsionpolicy.com/the-ultra-rare-effect-stealth-bio-s-elamipretide-for-barth-syndrome-wins-split-vote-from-cardio-renal-advisory-committee-despite-thin-evidence-of-efficacy 2024-10-11 weekly 0.9 https://staging.previsionpolicy.com/cbo-drug-pricing-options-international-reference-pricing-would-have-large-effect-but-expanding-ira-would-not-report-raises-questions-about-march-in-approach 2024-10-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-oce-s-pazdur-celebrates-25-years-at-fda-but-he-s-not-thinking-of-retirement-i-m-just-beginning-here 2024-10-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hurricane-helene-underscores-fda-shortage-messages-commissioner-califf 2024-10-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lilly-tirzepatide-shortage-status-now-uncertain-fda-backs-down 2024-10-15 weekly 0.9 https://staging.previsionpolicy.com/oncology-drug-reproductive-toxicity-fda-guidance-on-ovarian-toxicity-monitoring-coming-soon-fda-asco-urge-collection-of-serum-biomarker-and-clinical-measures-during-workshop 2024-10-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-rare-disease-endpoint-advancement-pilot-has-two-participants 2024-10-16 weekly 0.9 https://staging.previsionpolicy.com/fda-on-oncology-r-d-trends-patient-registries-as-external-controls-not-yet-ready-for-prime-time-fda-is-thinking-very-deeply-about-digital-twins 2024-10-16 weekly 0.9 https://staging.previsionpolicy.com/ira-small-biotech-exemption-expansion-is-on-gop-post-election-wish-list-prv-reauthorization-challenging-enough-without-revisions 2024-10-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-long-term-clinical-neurodevelopmental-safety-studies-in-neonatal-product-development-final-guidance-includes-modest-changes 2024-10-17 weekly 0.9 https://staging.previsionpolicy.com/rare-disease-reviews-at-fda-support-for-outside-the-box-thinking-by-agency-showcased-at-nord-meeting 2024-10-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-rfk-jr-would-clear-out-senior-fda-officials-in-certain-categories-like-nutrition 2024-11-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-methodological-challenges-to-patient-experience-data-fda-workshop-dec-13 2024-10-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-rfk-warns-fda-preserve-your-records-and-pack-your-bags 2024-10-28 weekly 0.9 https://staging.previsionpolicy.com/pandemic-influenza-preparedness-h5-strain-updates-will-begin-in-inter-pandemic-period-vrbpac-eager-for-mrna-options-but-current-focus-is-on-approved-products 2024-10-17 weekly 0.9 https://staging.previsionpolicy.com/cms-announces-sample-drug-list-for-2-generics-model-2027-is-earliest-possible-start-date 2024-10-17 weekly 0.9 https://staging.previsionpolicy.com/lame-duck-session-could-still-be-eventful-for-biopharma-initial-post-election-read-is-to-anticipate-short-term-cr-through-march-unless-trump-wants-clean-slate-for-2025 2024-11-08 weekly 0.9 https://staging.previsionpolicy.com/pazdur-celebrates-25-years-at-fda-with-former-commissioners-next-agency-chief-should-examine-your-internal-compass-and-stick-to-it-califf-says 2024-10-28 weekly 0.9 https://staging.previsionpolicy.com/re-scoring-the-ira-part-d-overhaul-costs-are-higher-than-cbo-projected-for-2025-more-than-offsetting-higher-than-projected-price-negotiation-savings 2024-10-17 weekly 0.9 https://staging.previsionpolicy.com/rfk-declares-war-on-fda-would-trump-really-let-him-go-wild-on-medicines 2024-10-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-patient-engagement-advisory-committee-will-be-asked-to-identify-important-elements-in-informed-consent 2024-10-29 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-disrupting-fda-agency-managers-unsure-of-who-is-laid-off-until-notified-by-affected-staff 2025-02-19 weekly 0.9 https://staging.previsionpolicy.com/make-hhs-anti-industry-again-kennedy-blames-system-not-the-people-for-inefficient-dysfunctional-or-corrupt-agencies-in-first-address-to-staff 2025-02-19 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-gene-cell-therapy-leadership-team-appears-set-for-first-public-presentations-of-trump-era 2025-02-20 weekly 0.9 https://staging.previsionpolicy.com/medicare-adds-former-trump-i-official-aramanda-as-principal-deputy-director-former-omber-albanese-is-policy-advisor 2025-02-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-vaccine-disruption-begins-acip-meeting-postponed 2025-02-21 weekly 0.9 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https://staging.previsionpolicy.com/fda-commissioner-nominee-makary-clears-committee-after-chief-counsel-departs-cdc-nominee-weldon-withdrawn-by-white-house 2025-03-13 weekly 0.9 https://staging.previsionpolicy.com/fda-rare-disease-case-studies-illustrate-dose-optimization-sanofi-s-xenpozyme-and-single-trial-efficacy-standard-sentynyl-s-nulibry 2025-03-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-flu-strain-selections-announced-by-fda-after-internal-meeting 2025-03-14 weekly 0.9 https://staging.previsionpolicy.com/cms-nominee-oz-delivers-wizardly-performance-in-confirmation-hearing-drug-pricing-is-not-major-focus-but-oz-pledges-to-use-price-negotiation-support-sickle-cell-demo 2025-03-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-return-to-office-day-for-fda-expect-disruptions 2025-03-17 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-most-favored-nation-drug-pricing-options-outlined-by-gop-think-tank 2025-03-21 weekly 0.9 https://staging.previsionpolicy.com/a-glow-up-for-vaers-rebranding-vaccine-safety-systems-with-more-robust-community-level-data-could-address-vaccine-hesitancy-gottlieb-says 2025-03-21 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-white-oak-u-turn-senate-help-general-counsel-barrett-tenbarge-to-remain-with-committee-no-longer-headed-to-fda 2025-03-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-concepts-of-a-plan-fda-streamlining-will-result-in-five-shared-services-offices-hhs-says 2025-04-04 weekly 0.9 https://staging.previsionpolicy.com/fda-guidance-could-be-key-to-encouraging-studies-of-indirect-benefits-from-infectious-disease-treatments-regulatory-payment-policy-could-help-uptake-margolis-authors-suggest 2025-03-28 weekly 0.9 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https://staging.previsionpolicy.com/fda-cuts-hit-hard-cber-acting-director-is-scott-steele-after-tierney-departs-ond-s-stein-is-another-leadership-loss-biggest-impact-may-be-deleted-divisions-offices 2025-04-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-after-the-rifs-reorganization-plan-with-center-consolidation-likely 2025-04-02 weekly 0.9 https://staging.previsionpolicy.com/maha-vision-for-fda-includes-new-pathways-for-root-cause-treatments-but-not-traditional-big-pharma-hhs-advisor-means-says-layoffs-reflect-failure-of-agencies 2025-04-02 weekly 0.9 https://staging.previsionpolicy.com/makary-introduces-himself-to-fda-staff-our-country-needs-you-i-will-do-my-best-to-assure-resources-covid-response-critic-hoeg-joins-as-special-advisor 2025-04-02 weekly 0.9 https://staging.previsionpolicy.com/fda-cuts-may-impact-complex-generic-reviews-inspections-despite-intent-to-keep-applications-moving-former-commissioner-gottlieb-says 2025-04-03 weekly 0.9 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0.9 https://staging.previsionpolicy.com/pbm-reforms-remain-live-topic-on-capitol-hill-while-ftc-chaos-stalls-insulin-case 2025-04-11 weekly 0.9 https://staging.previsionpolicy.com/fda-to-phase-out-animal-testing-for-monoclonals-fda-commissioner-makary-says-pilot-test-in-2025-aims-to-lead-to-broader-changes-as-nam-process-moves-forward 2025-04-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-glp-1-agonist-coverage-in-medicaid-medicare-regulatory-framework-still-under-consideration 2025-04-14 weekly 0.9 https://staging.previsionpolicy.com/rfk-at-fda-dissidents-will-be-listened-to-hhs-secretary-kennedy-says-commissioner-makary-calls-for-more-teamwork-less-individual-empires 2025-04-11 weekly 0.9 https://staging.previsionpolicy.com/fda-five-office-reorg-proposal-criticized-by-former-senior-officials-regulatory-work-is-too-specialized-for-a-big-team-of-generalists 2025-04-11 weekly 0.9 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2025-04-24 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-merck-bristol-reassure-investors-that-fda-reviews-are-proceeding-on-time-for-now 2025-04-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-novavax-covid-vaccine-delay-commissioner-makary-confirms-demand-for-clinical-trial 2025-04-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-no-fda-reorganization-planned-commissioner-makary-says 2025-04-29 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-covid-booster-panel-could-be-tone-setter-for-makary-s-tenure-if-it-happens-fda-public-meeting-cancellations-continue-into-spring 2025-04-29 weekly 0.9 https://staging.previsionpolicy.com/drug-reviews-are-on-time-fda-s-makary-testifies-missed-goal-dates-are-due-to-complexity-not-cuts-proposed-11-5-budget-cut-will-not-fly-sen-murray-declares 2025-05-22 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-sarepta-elevidys-reversal-fda-lifts-hold-for-ambulatory-dmd-patients 2025-07-30 weekly 0.9 https://staging.previsionpolicy.com/fda-precheck-domestic-manufacturing-proposal-features-pre-operations-phase-1-phase-2-to-offer-advanced-awareness-of-strategies-for-specific-drugs 2025-08-07 weekly 0.9 https://staging.previsionpolicy.com/rx-to-otc-switch-framework-provisions-added-to-omufa-reauthorization-in-senate-fda-would-identify-switch-candidates-and-work-with-sponsors 2025-07-30 weekly 0.9 https://staging.previsionpolicy.com/fda-project-orbis-up-to-118-approvals-project-nozomi-will-facilitate-submissions-in-japan-pazdur-makes-plug-for-expanding-to-other-therapeutic-areas 2025-07-30 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pilot-testing-a-single-center-cder-director-tidmarsh-will-serve-as-cber-acting-director 2025-07-31 weekly 0.9 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https://staging.previsionpolicy.com/fda-deadline-tracker-a-record-year-for-nmes-commissioner-makary-aiming-high-despite-ongoing-turmoil-at-the-agency-other-deadlines-may-suffer 2025-08-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-chief-counsel-is-sean-keveney 2025-08-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hhs-ends-mrna-vaccine-development-under-barda-no-new-mrna-based-projects-will-be-initiated 2025-08-06 weekly 0.9 https://staging.previsionpolicy.com/drug-quality-assurance-inspections-are-closer-to-pre-pandemic-levels-but-still-behind-china-leads-jump-in-foreign-sites-cder-report-finds 2025-08-11 weekly 0.9 https://staging.previsionpolicy.com/ftc-doj-on-drug-pricing-balance-needed-between-patent-rights-and-reforms-uspto-warns-against-overregulation-in-final-listening-session 2025-08-11 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-fda-will-present-updated-coa-evidence-dossier-template-at-sept-18-19-workshop 2025-08-19 weekly 0.9 https://staging.previsionpolicy.com/os-in-oncology-pivotal-trials-should-include-plans-to-rule-out-harm-when-survival-is-not-the-endpoint-fda-says-accelerated-approval-is-option-to-address-uncertainty 2025-08-19 weekly 0.9 https://staging.previsionpolicy.com/rwe-in-2025-focus-should-be-on-methodologic-expertise-transparency-measures-some-stakeholders-call-for-updates-to-fda-guidances 2025-09-23 weekly 0.9 https://staging.previsionpolicy.com/fda-oncology-therapeutic-radiopharmaceutical-dosage-optimization-guidance-includes-strategies-to-handle-delayed-toxicities-patients-with-previous-radiation-therapy 2025-08-20 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-user-fee-financial-transparency-meeting-set-for-september-30 2025-08-20 weekly 0.9 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0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-biohaven-troriluzole-no-longer-going-to-panel-as-meeting-drought-continues-hhs-launching-new-federal-healthcare-cmte 2025-08-25 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-to-consider-narrowed-indication-under-expedited-re-review-of-vanda-s-hetlioz-for-jet-lag 2025-10-02 weekly 0.9 https://staging.previsionpolicy.com/fda-reiterates-cautious-iterative-approach-to-novel-cancer-endpoints-added-development-time-helps-build-buy-in-from-clinical-community 2025-10-02 weekly 0.9 https://staging.previsionpolicy.com/fda-hiring-and-retention-report-stresses-importance-of-telework-pre-trump-administration-data-find-low-attrition-high-satisfaction 2025-08-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-neuroscience-office-changes-laura-jawidzik-is-leading-division-of-neurology-2 2025-08-27 weekly 0.9 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2025-09-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pediatric-priority-review-voucher-reauthorization-set-for-mark-up 2025-09-16 weekly 0.9 https://staging.previsionpolicy.com/dtc-crackdown-starts-with-glp-1s-compounders-lilly-novo-all-get-warning-letters-fda-sends-40-untitled-letters-to-other-rx-firms 2025-09-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-house-gop-continuing-resolution-includes-omufa-reauthorization-with-rx-to-otc-switch-provisions 2025-09-17 weekly 0.9 https://staging.previsionpolicy.com/cdc-oversight-hearing-casts-shade-on-fda-kennedy-told-ousted-director-that-other-agencies-were-more-compliant-hepatitis-b-vaccine-newborn-use-is-one-potential-change 2025-09-17 weekly 0.9 https://staging.previsionpolicy.com/cell-gene-therapy-innovative-trial-designs-include-using-patients-as-their-own-control-one-of-six-options-recommended-in-fda-draft-guidance 2025-09-24 weekly 0.9 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https://staging.previsionpolicy.com/astrazeneca-camizestrant-ctdna-guided-breast-cancer-indication-fails-at-odac-first-line-trial-may-be-most-likely-path-to-market 2026-04-30 weekly 0.9 https://staging.previsionpolicy.com/astrazeneca-s-truqap-snda-will-face-uphill-battle-at-odac-magnitude-of-clinical-benefit-plus-fatal-toxicities-will-make-for-tough-review 2026-04-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-one-prasad-position-filled-mallika-mundkur-is-fda-s-acting-chief-medical-and-scientific-officer 2026-04-29 weekly 0.9 https://staging.previsionpolicy.com/fda-to-launch-real-time-clinical-trial-pilot-in-august-commissioner-highlights-amgen-az-studies-as-proof-of-concept 2026-04-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cber-deputy-szarama-will-be-acting-center-director-for-now 2026-05-01 weekly 0.9 https://staging.previsionpolicy.com/fda-deadline-tracker-april-decisions-continue-mixed-messages-about-regulatory-flexibility-cnpv-actions-are-changing-timelines 2026-05-04 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-proposes-not-to-include-semaglutide-tirzepatide-and-liraglutide-on-503b-bulks-list 2026-05-01 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-angelo-de-claro-named-permanent-director-of-fda-oncology-center-of-excellence 2026-05-05 weekly 0.9 https://staging.previsionpolicy.com/fda-s-plausible-mechanism-framework-is-on-a-spectrum-of-regulatory-flexibility-for-ultra-rare-diseases-otp-details-approach-for-gene-edited-products 2026-05-05 weekly 0.9 https://staging.previsionpolicy.com/astrazeneca-crestor-switch-could-be-early-test-of-acnu-pathway-at-fda-sponsors-urge-acceptance-of-real-world-data-ai-to-help-support-switch-applications 2026-05-05 weekly 0.9 https://staging.previsionpolicy.com/quantitative-biopharmaceutics-is-the-future-for-innovative-bioequivalence-determinations-fda-s-lionberger-says-ai-makes-new-approaches-feasible 2026-05-05 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cell-gene-therapy-cmc-flexibilities-guidance-urges-sponsors-to-leverage-prior-knowledge-in-cmc-development-justify-batches 2026-05-06 weekly 0.9 https://staging.previsionpolicy.com/how-far-will-anti-china-sentiment-go-house-report-would-direct-fda-to-refuse-data-from-china-implementation-unlikely-but-message-is-still-significant 2026-05-06 weekly 0.9 https://staging.previsionpolicy.com/ai-enabled-one-day-screening-pilot-launches-with-focus-on-low-risk-facilities-fda-commissioner-makary-says-ind-reforms-will-cut-unnecessary-information 2026-05-06 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-commissioner-martin-makary-will-testify-at-may-13-senate-appropriations 2026-05-07 weekly 0.9 https://staging.previsionpolicy.com/cber-endorses-non-traditional-approaches-in-cmc-development-for-cell-gene-therapies-in-guidance-aimed-at-flexibilities-to-lower-burden-on-sponsors 2026-05-07 weekly 0.9 https://staging.previsionpolicy.com/first-in-china-trials-may-prove-counterproductive-for-sponsors-otp-s-kumar-says-during-focr-event-cmc-delays-remain-key-factor-slowing-car-t-development 2026-05-07 weekly 0.9 https://staging.previsionpolicy.com/fda-s-first-public-cnpv-review-memo-otarmeni-summary-basis-of-approval-provides-little-insight-into-novel-review-process 2026-05-07 weekly 0.9 https://staging.previsionpolicy.com/acting-cber-director-szarama-emphasizes-stability-for-staff-says-sponsor-characterizations-of-late-stage-development-advice-reversals-are-just-one-perspective 2026-05-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-reviewing-about-150-comments-on-plausible-mechanism 2026-05-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-dead-man-walking-makary-is-still-commissioner-despite-a-week-of-headlines 2026-05-11 weekly 0.9 https://staging.previsionpolicy.com/advisory-committee-tracker-moderna-flu-vaccine-set-for-june-review-sanofi-tzield-cnpv-indication-meeting-in-the-works-adjudicating-the-makary-era 2026-05-26 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-pdufa-viii-agreement-is-set-next-steps-outlined 2026-05-27 weekly 0.9 https://staging.previsionpolicy.com/fda-considers-broadening-nmibc-bladder-cancer-drug-use-beyond-patients-with-cis-agency-continues-to-encourage-drug-development-in-period-of-bcg-shortage 2026-05-27 weekly 0.9 https://staging.previsionpolicy.com/revamping-drug-shortages-creating-a-domestic-supply-seems-to-have-new-energy-under-trump-but-stakeholders-caution-that-guardrails-are-needed 2026-05-27 weekly 0.9 https://staging.previsionpolicy.com/one-day-inspectional-assessments-could-generate-483s-but-do-not-replace-standard-inspections-fda-s-miller-says-precheck-program-expansion-in-active-discussion 2026-05-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-single-trial-policy-in-action-outlook-will-resubmit-ophthalmic-bevacizumab-bla 2026-05-28 weekly 0.9 https://staging.previsionpolicy.com/fda-drug-repurposing-initiative-rfi-seeks-candidates-for-new-indication-approvals-asks-for-input-on-barriers-to-off-label-use-ways-fda-can-help 2026-05-11 weekly 0.9 https://staging.previsionpolicy.com/anti-aging-claims-and-fda-intrinsic-capacity-may-have-potential-as-an-endpoint-fdaers-suggest-but-progress-likely-begins-with-studies-of-mortality-disease-prevention 2026-05-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-another-normal-vrbpac-committee-backs-fda-covid-19-vaccine-strain-update 2026-05-29 weekly 0.9 https://staging.previsionpolicy.com/checkpoint-inhibitors-cd3s-do-not-need-three-month-animal-tox-studies-fda-says-in-draft-guidance-on-oncology-biologics 2026-05-29 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-may-mixers-fda-acting-commissioner-diamantas-meets-with-key-lawmakers-trade-groups 2026-06-01 weekly 0.9 https://staging.previsionpolicy.com/ai-use-at-fda-senior-leaders-describe-rapid-adoption-across-centers-halo-upgrade-will-help-aggregate-background-info-for-reviewers 2026-05-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cder-biomarker-incubator-launched-first-pilot-will-seek-data-on-markers-of-kidney-toxicity 2026-05-12 weekly 0.9 https://staging.previsionpolicy.com/bsufa-iv-negotiations-making-progress-combination-product-enhancements-are-key-industry-ask-in-current-round-america-first-provisions-will-carry-over-from-pdufa 2026-06-01 weekly 0.9 https://staging.previsionpolicy.com/another-normal-vrbpac-but-neither-fda-nor-committee-sees-covid-strain-selection-as-routine-agency-open-to-changing-timeline-for-selections-but-warns-of-tradeoffs 2026-06-01 weekly 0.9 https://staging.previsionpolicy.com/acting-commissioner-diamantas-likely-to-run-fda-through-mid-terms-after-makary-exits-management-uncertainty-reigns-with-cnpv-future-in-doubt 2026-05-12 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-acting-commissioner-diamantas-takes-the-reins-at-fda 2026-05-13 weekly 0.9 https://staging.previsionpolicy.com/fda-final-pregnancy-safety-guidance-adds-expectations-for-registry-feasibility-studies-and-postpartum-monitoring 2026-05-13 weekly 0.9 https://staging.previsionpolicy.com/cder-biomarker-incubator-initiative-launched-first-pilot-will-focus-on-kidney-toxicity-fda-asks-for-data-and-potential-next-topics 2026-05-13 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-gene-editing-leveraging-knowledge-draft-guidance-released-for-comment 2026-06-02 weekly 0.9 https://staging.previsionpolicy.com/fda-gene-editing-leveraging-draft-guidance-provides-menu-of-options-for-sponsors-to-build-on-prior-knowledge-principles-may-apply-more-broadly-to-other-cgts-fda-says 2026-06-02 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-reissues-non-opioid-acute-pain-draft-guidance-invites-further-comment 2026-05-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-uniqure-huntington-s-gene-therapy-back-on-track-for-accelerated-approval-filing 2026-06-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-senate-help-advances-two-drug-pricing-bills-act-for-als 2026-06-18 weekly 0.9 https://staging.previsionpolicy.com/balance-weight-loss-coverage-model-delay-partially-due-to-pressure-on-part-d-plans-amid-ira-changes-cms-brooks-says-lilly-eager-to-test-different-approaches-if-medicare-can-be-flexible 2026-05-14 weekly 0.9 https://staging.previsionpolicy.com/is-there-a-future-for-cnpv-any-modifications-should-balance-accelerated-review-against-ensuring-public-trust-industry-execs-say 2026-06-18 weekly 0.9 https://staging.previsionpolicy.com/clinical-trial-reform-discussion-draft-released-to-frame-issues-ahead-of-user-fee-reauthorization-rare-disease-hub-codification-included 2026-05-14 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-a-new-fda-commissioner-by-summer 2026-05-15 weekly 0.9 https://staging.previsionpolicy.com/cber-fully-supports-nams-leveraging-preclinical-data-for-car-ts-fda-s-fleischer-says-sponsors-would-like-more-clarity-when-guidance-does-or-does-not-apply-to-cgts 2026-05-15 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-fda-leadership-reset-cder-cber-have-new-directors-again 2026-05-18 weekly 0.9 https://staging.previsionpolicy.com/the-human-touch-acting-cder-director-davis-introduces-himself-at-redi-conference-emphasizes-that-human-expert-judgment-remains-core-to-fda-decisions 2026-05-20 weekly 0.9 https://staging.previsionpolicy.com/fda-deadline-tracker-eight-nmes-clear-agency-in-may-and-june-could-be-just-as-busy-az-camizestrant-gets-a-three-month-reprieve 2026-06-02 weekly 0.9 https://staging.previsionpolicy.com/clear-labels-act-is-just-the-start-of-congressional-attention-to-the-drug-supply-senate-staffer-says-but-a-comprehensive-package-will-take-time 2026-05-21 weekly 0.9 https://staging.previsionpolicy.com/fda-updates-payor-communication-guidance-to-reflect-statutory-change-substance-of-2018-advice-unchanged 2026-06-02 weekly 0.9 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https://staging.previsionpolicy.com/lessons-in-quality-management-maturity-preventive-risk-based-maintenance-ensures-operational-reliability-fda-says 2026-06-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-user-fee-reauthorization-particularly-important-due-to-fda-staffing-cuts-political-dynamics-sen-kaine 2026-06-10 weekly 0.9 https://staging.previsionpolicy.com/accelerated-approval-for-biomarkers-focr-working-group-proposes-tiered-approach-with-clearer-interim-signals-as-part-of-revised-biomarker-qualification-pathway 2026-06-11 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-who-fired-hoeg-former-cder-director-suggests-the-pharmaceutical-industry 2026-06-11 weekly 0.9 https://staging.previsionpolicy.com/fda-encouraging-patient-centric-dosage-forms-for-generic-drugs-workshop-highlights-suitability-petitions-as-route-to-enable-easier-to-swallow-formulations 2026-06-11 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-expedited-ind-pilot-launches-fda-sets-october-30-deadline-for-applications 2026-09-16 weekly 0.9 https://staging.previsionpolicy.com/expedited-ind-pilot-launches-with-8-10-candidates-for-rolling-review-to-be-selected-by-mid-december-novel-therapies-us-based-trials-to-be-prioritized 2026-09-16 weekly 0.9 https://staging.previsionpolicy.com/cder-crls-have-been-trending-down-over-time-fda-report-says-though-novel-blas-are-an-outlier-report-intended-to-rebut-headlines-about-2025-rejections 2026-09-16 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-biotech-innovation-and-biosecurity-house-science-space-and-technology-oversight-subcommittee-hearing-sept-16 2026-09-17 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hhs-deputy-surgeon-general-nominee-have-smooth-confirmation-hearing 2026-09-17 weekly 0.9 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https://staging.previsionpolicy.com/prevision-policy-clips-gene-editing-platforms-fda-draft-guidance-describes-approach-to-single-bla-for-multiple-variants 2026-10-27 weekly 0.9 https://staging.previsionpolicy.com/bsufa-iv-agreement-features-streamlined-supplement-structure-cmc-readiness-program-includes-notification-of-pre-license-inspections-opportunity-for-corrective-action-prior-to-bla-goal-date 2026-09-30 weekly 0.9 https://staging.previsionpolicy.com/gene-editing-treatments-for-monogenic-diseases-fda-guidance-would-allow-multiple-variants-in-same-bla-individualized-feature-space-is-key-regulatory-concept 2026-10-27 weekly 0.9 https://staging.previsionpolicy.com/cber-encourages-next-generation-sequencing-to-detect-adventitious-agents-in-biological-products-as-part-of-broader-fda-promotion-of-nams 2026-09-30 weekly 0.9 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https://staging.previsionpolicy.com/rare-disease-advocates-should-unite-behind-system-changes-ex-cder-head-woodcock-urges-gene-editing-guidance-is-type-of-change-woodcock-wants-to-see 2026-10-27 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-340b-rebate-model-10-manufacturers-join-pilot-program 2026-10-07 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-lone-star-arrowhead-s-redemplo-for-severe-hypertriglyceridemia-selected-for-fda-real-time-review-pilot 2026-10-08 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-former-fda-principal-deputy-sharfstein-joins-senate-dem-s-public-health-working-group 2026-10-09 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-hhs-acting-general-counsel-is-benjamin-robles 2026-10-13 weekly 0.9 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https://staging.previsionpolicy.com/cmc-facility-prep-components-of-bsufa-iv-agreement-praised-by-fda-and-industry-during-public-review-of-commitment-letter-changes-reflect-maturing-program 2026-10-28 weekly 0.9 https://staging.previsionpolicy.com/prevision-policy-clips-cms-cell-gene-therapy-access-model-will-expand-beyond-sickle-cell-disease-rfas-coming-soon 2026-10-28 weekly 0.9 https://staging.previsionpolicy.com/sydnexis-atropine-ophthalmic-appeal-will-showcase-new-era-for-advisory-committees-fda-has-long-list-of-efficacy-concerns-and-is-not-asking-for-a-vote 2026-10-28 weekly 0.9 https://staging.previsionpolicy.com/now-is-the-moment-for-us-to-step-in-fda-center-directors-explain-drivers-for-rare-disease-framework-key-goals-for-early-implementation 2026-10-28 weekly 0.9 https://staging.previsionpolicy.com/fda-drug-inspection-operations-update-features-more-involvement-of-drug-center-conops-2-0-revision-includes-remote-regulatory-assessments 2026-10-30 weekly 0.9 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