Prevision Policy Clips | Kennedy Defends Replimune Rejection: “Marty Made The Correct Decision"

“Abbreviated BLA” Pathway Discussed At Senate HELP Hearing: MedPAC’s Miller Proposes Streamlined Biosimilar Requirements To Increase Competition

Prevision Policy Clips | FDA Planning Second Peptide Compounding Advisory Committee “Before The End Of February 2027”

CDER’s Innovative Trial Pilots Slow To Launch: Acceptance From Other Regulators Is One Reason, But Industry May Need To “Get Over” Risk Intolerance

ACT For ALS Reauthorization, Codification Of FDA Wearables Guidance Have Bipartisan Support In House; Is PAHPA Reauthorization Back On The Table?

Prevision Policy Clips | FDA “Single-Trial” Standard: “Burden Of Proof” Still On Sponsors

FDA Plays Hardball In GDUFA Negotiations: Threatens To Pull ANDA Priority Review Pilot; Finance Proposals Still Missing As Other Priorities Move Forward

CMS Takes Hard Line On NTAP Applications In Proposed Rule; Omeros’ Yartemlea Is Only Drug Agency Is Ready To Endorse For FY2027; Antibiotic Shortcut Pathway Would Be Eliminated

Gene-Editing “Off-Target” Effects: FDA Outlines Pre-Clinical Safety Testing Expectations In New Draft Guidance

Prevision Policy Clips | Lilly Foundayo Approval Letter Confirms January 20 Filing Date

FDA “PreCheck” Takes Shape: Agency Provides Additional Details On Domestic Manufacturing Facility Development Pilot

FDA, Industry March Toward PDUFA VIII Commitment Letter With Tweaks To Regulatory Decision-Making Proposals, Most Recent Meeting Minutes Show

Repeal And Replace Prior Authorization? Democratic Think Tank Proposes “Ban” On PA; CMS Wants To Add Drugs To Electronic PA Standards, Eyes Reforms To Step Therapy

Prevision Policy Clips | Replimune Rejected Again: New Review Team At FDA Is “Unanimous”

Prevision Policy Clips | CBER OTP Head Kumar Offers “Candid” Assessment Of Challenges With Pediatric Cell & Gene Therapy

External Control Arm Lessons Learned: Sponsors Should Design Trials To Fit Real-World Data, FOCR Panelists Suggest

Prevision Policy Clips | PhRMA CEO Ubl To Step Down Once A Replacement Is Named

Externally Controlled Trials: FDA Exploring Hybrid Designs For Possible Future Guidance; Working On “Solutions” To Simplify Patient-Level Data Submission

Prevision Policy Clips | Democratic Think Tank Proposes To “Ban And Replace” Prior Authorization

PDUFA VIII Update: FDA, Industry Agree On New Fee For First Non-Orphan Supplements; “America First” Phase 1 Trial “Anchoring” Incentive Still In Discussion

CBER Director Search Includes External Candidates: Biotech Exec Hemmati In The Mix, Uncommon Cures CEO Summar Also Considered

Prevision Policy Clips | FDA To Hold PFDD Meeting On Nonhealing Chronic Wounds August 25

ANDA Priority Review Pilot GDUFA Language Finalized, But Impasse Over Financing Persists And Concerns Emerge About Bonuses For Faster Reviews

FDA Legislative Wish List Includes New IND Pathway, Advisory Committee Reforms – But Not CNPV Codification; Agency Fares Well In Context Of White House Budget Plans

Prevision Policy Clips | CBER Budget Would Shrink Under FDA FY 2027 Budget Request