Prevision Policy Clips | AZ/Sanofi Nirsevimab Coverage Recommendation Will Be Voted On By ACIP

House GOP Plans Separate Drug Shortage Bill; Energy & Commerce Health Subcommittee Advances “Clean” PAHPA Bills On Party-Line Vote

Prevision Policy Clips | GAO Issues Regenerative Medicines Report

PMR Enforcement Guidance Outlines Acceptable Excuses For Delays: “Good Cause” Reasons For Missed Study Milestones Exist, FDA Says – But Sponsors Still Need To Take Corrective Action

Gene Therapy Manufacturing Changes: FDA Draft Guidance Urges Sponsors To Use Commercial Process For Pivotal Trials Whenever Possible

Prevision Policy Clips | CBER Cell/Gene Therapy Manufacturing Changes Draft Guidance

FDA Oncology Diagnostic Pilot Aims To Enroll Diverse Set Of Sponsors To Try Alternative Approach To Targeted Therapy; Goal Is To Align Regulation To Real-World Testing Practice

Prevision Policy Clips | FDA Oncology Center Sees Stockpiles As Potential Long-Term Solution To Cancer Drug Shortages

Leqembi PMRs Will Be Incorporated Into CMS Registry Process, Agency’s Fleisher Tells FOCR; FDA Notes Need To Collect Data Beyond Normal Practice

Prevision Policy Clips | HELP Committee Chair Bernie Sanders (I-Vt.) Pushes Again For Lecanemab Price Reduction

Prevision Policy Clips | IRA Part D Out-Of-Pocket Savings: HHS Report

Leqembi Alzheimer’s Registry Appears To Pose Minimal Barrier To Uptake With “Full” FDA Approval In Hand; ApoE Screening Recommended In Label – But Not A Condition For Medicare

Prevision Policy Clips | Leqembi Boxed Warning Recommends ApoEε4 Screening Prior To Starting Treatment

Advisory Committee Tracker: FDA Enters Summer Lull After Blistering Start To 2023; 18 Of 19 Meetings Have Been Positive For Sponsors YTD

Prevision Policy Clips | Cell and Gene Therapy Nonclinical Assessment: CBER Schedules Town Hall Event For Aug. 30

PAHPA Reauthorization Draft Includes “Disease X” Provision, But Supply Chain Transparency Measures, VALID And Antibiotic Development Incentives Are Out

Prevision Policy Clips | Senate HELP PAHPA Discussion Draft Includes Disease X Act, Policies “Outside the Staff Agreement” For “Stakeholder Feedback”

CMS Adds Patient “Sessions” To Negotiation Process To Address Therapeutic Alternatives; Revised IRA Guidance Continues Narrow Protection For Orphan Drugs

Prevision Policy Clips | Genentech/Blueprint Withdraw Gavreto (Pralsetinib) Accelerated Approval For Advanced Medullary Thyroid Cancer

Prevision Policy Clips | IRA Medicare Drug Price Negotiation Revised Guidance: CMS Restates “Confidentiality Policy” To Allow Agency To Release Information On Negotiations

Prevision Policy Clips | ICER President-Elect Sarah Emond Starts 18-Month Transition Period With Founder Steve Pearson

From Flop To FOP: Ipsen’s Palovarotene Rescued By FDA Panel’s Acceptance Of Post Hoc Analyses For Ultra-Rare Condition Affecting 800 Patients

FDA Details ORA Reorg Proposal: Seven Inspection Offices Will Be Independent Of “Cross-Cutting” Functions; Finalized Plans On Track For Fall Publication

Prevision Policy Clips | FDA Releases Org Chart For Proposed Office Of Regulatory Affairs Reorganization, Announces Additional Changes

Psychedelic Clinical Investigations Draft Guidance Outlines “Complementary” Designs To Traditional Placebo Trials; Addresses Dose-Response, Valvulopathy, And Psychological Intervention