Prevision Policy Clips | Genentech Pulls Tecentriq Breast Cancer Indication: Another “Dangling” Accelerated Approval

Prevision Policy Clips | Drug Price Reporting Requirement For Health Plans Will Be Delayed By One Year

CBO Updated Drug Price Negotiation Model Sees Less Impact From Democratic Proposals; R&D Output Would Drop 0.5% In First Decade; 5% In Second

REMS Assessment Upgrade Set For PDUFA VII, Addressing Key Ongoing Liability For FDA; Sentinel Role In RWE Will Be Tested

Digital Health Tools For Regulatory Decisions: FDA Framework And Guidances Are PDUFA VII Goals; “Cloud Technology” Gets Big Push

Prevision Policy Clips | Moderna Completes Submission For Full COVID-19 Vaccine Approval

PDUFA VII Rare Disease Pilot Will Offer Extensive Support On Novel Endpoints In Exchange For Public Disclosure; Opportunities To Participate Will Also Be Rare

PD-1 Alternative Dosing Schedules Can Use PK Data For Approval; FDA Draft Guidance Builds On Efforts To Minimize Patient Visits During COVID

Prevision Policy Clips | Checkpoint Inhibitor Dose Optimization: FDA Outlines Streamlined Pathway For New Dosing Regimens

Gene/Cell Therapy Review Upgrades In PDUFA VII Will Produce Five New Guidances Along With New Staff

Physical Function PROs During Cancer Trials May Be Made Easier By Remote Monitoring; FDA Focused On First Six Months

Increased Interaction Is Key Theme In PDUFA VII Deal: INTERACT (Pre-Pre-IND) Meetings Expand To CDER, Clarifying Questions Will Be Taken

Prevision Policy Clips | ICER RWE Update Finds Hereditary Angioedema Therapies "Far Less Cost-Effective"

Real Time Review Pilot Is “STAR” Of PDUFA VII Agreement, But New Combination Product, PMR Goals May Have Much Bigger Impact For Sponsors

Gene Therapy Dosing Limits To Be Discussed By FDA Advisory Committee; Toxicity Review Likely Aimed At Public Education Rather Than Immediate Changes

BLA Approval Of Pfizer/BioNTech COVID-19 (Comirnaty) Vaccine Includes Six Postmarket Requirements On Myocarditis/Pericarditis

PDUFA VII Agreement Gives FDA $100 Million Raise For FY 23, Funds 352 New FTEs Over Five Years: Cell/Gene Therapy Reviews, Bioinformatics Support Will Benefit

Prevision Policy Clips | PDUFA VII: FDA/Industry User Fee Agreement Includes New PMR Review Goals, Tests Broader “Real Time” Review

Prevision Policy Clips | FDA Anti-Infectives Division Director Nambiar Departs After 9 Years

Prevision Policy Clips | COVID-19 Vaccine Boosters Ready For General Population Week Of September 20, President Biden

Prevision Policy Clips | President Biden Expected To Discuss COVID-19 Booster Shots In White House Remarks Today

Part B Discarded Dose Rebate Would Kick In Jan. 1, 2023 Under Bipartisan Infrastructure Bill; New Drugs Exempt For 18 Months, HHS Could Set More Exceptions Via Rulemaking

Prevision Policy Clips | COVID-19 Vaccine Boosters On ACIP Agenda August 24; Pfizer/BioNTech Could Be Up For A Vote

ACIP Readies For COVID Vaccine Boosters: Policy Framework Suggests Same Priority Order As Original Doses – Once FDA Signs Off

Prevision Policy Clips | OCHEN Deputy Mary Thanh Hai Likely to Head Office Following Ellis Unger’s Retirement From FDA