FDA Drug Repurposing Goal Should Be Adoption In Practice—Not Labeling Changes, Former Commissioner Woodcock Says

Ketamine, Long COVID Are Popular Targets For Repurposing In Comments On FDA RFI; “Rare Diseases” Ranks Third; FDA Will Have To Juggle Demands In Setting Framework

BsUFA IV Negotiations Conclude: Fee Structure Will Be Revised And Review Process Tweaked; FDA Sees “CMC Facility Lifecycle Program” As One Key Addition

Prevision Policy Clips | Moderna mRNA-Based Flu Vaccine Clears FDA, Using Dual Track Pathway

New Technology Add-On Payments: CMS Grants Three New Requests For Yartemlea, Gamifant, Zevaskyn; Rebuts Arguments That It Is Taking Harder Line With Cell & Gene Therapies

Prevision Policy Clips | FDA "RISE" Meeting September 29 Will Focus On “Statistical Considerations”

Senate Builds Support For Antibiotic Subscription Model (PASTEUR Act)

Prevision Policy Clips | FDA Formally Solicits Input Into Proposed “Quantitative Medicine Innovation Network"

FDA “Inspectional Affairs Council” To Set Priorities For OII; Agency Disclaims Any Move Towards “Generalist” Inspectors

Deadline Tracker: FDA Has 10 Novel Therapies With August Deadlines After Approving Six In July; Lipfendra CNPV Approval Is Quiet Record-Breaker

Prevision Policy Clips | CMS Grants Three New Technology Add-On Payment Requests

Biosimilar Combination Products: FDA Draft Guidance Outlines Expected Comparability Analysis For Device Components

Third Time’s A Charm For RP1: Replimune Melanoma Therapy Wins De Facto Appeal At FDA Advisory Committee, Likely Headed To Accelerated Approval

Prevision Policy Clips | Third Time’s A Charm For Replimune RP1: FDA Advisory Committee Strongly Supports Approval

Prevision Policy Clips | Part D Changes In IRA Net Positive For Drug Sector, CBO Analysis Indicates

Capricor’s Deramiocel For DMD Cardiomyopathy Voted Down By FDA Committee, But There May Be Potential For Indication In Upper Limb Function

Advisory Committee Tracker: Sydnexis Appeal Of Ophthalmic Atropine Will Be Next Topic Relitigated At Advisory Committee, But No Date Set

RWE Drug Submissions Still Require Patient-Level Data, But Changing That Is “Very Important,” FDA Official Says; “Lowering The Bar” Is Not Answer For RWE Adoption

PDUFA, BsUFA User Fee Rates Decline For FY 2027 Thanks To Carryover Funding; GDUFA Is Only Program To See Rate Increases

Prevision Policy Clips | Part D Instability May Spike Again After CMS Ends Premium Stabilization Demo

Replimune’s Last Chance: FDA Review Of RP1 Melanoma Agent Is Comprehensively Negative; Advisory Committee Represents De Facto Appeal Of CRLs

Prevision Policy Clips | Expedited IND Pilot Program: FDA Will Host Webinar August 6 “To Clarify The Intent Behind The Program”

End Of The Line For Deramiocel? FDA Finds No Benefit In DMD Cardiomyopathy In Resubmitted BLA, But Advisory Committee May Be More Flexible

FDA’s Compound Headache: Advisory Committee Peptide Votes Put Agency In A Quandary As It Navigates Kennedy And The Courts; Warning Sign Of How Other Committees Could Be Politicized?

Prevision Policy Clips | FDA And Peptides: What Happens Now?