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Gene-Editing “Off-Target” Effects: FDA Outlines Pre-Clinical Safety Testing Expectations In New Draft Guidance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

Prevision Policy Clips | Rx Tariffs Set To Take Effect September 29 For Companies Without MFN Pricing Deals; CGTs, Orphan Drugs Are Exempt

Makary’s State Of The FDA: Drug Review Reforms Featured In Internal Address; Single-Trial Policy Will Be Formalized, “Real Time Continuous Trial” Pilot Coming Soon

Prevision Policy Clips | Lilly Foundayo (Orforglipron) Clears FDA: Agency Claims Fastest NME Approval Since 2002

Prevision Policy Clips | FDA General Counsel Discusses Recent Rejections With Applicants

Maximum Daily Dose Database Advances In GDUFA Talks But Finance Proposals Continue To Stall; PLAIR Program Expansion Withdrawn

Rare Disease Data Sharing Research Agreements Could Be “Normalized” Through Financial Incentives; FDA’s “Plausible Mechanism” Guidance Is A Positive Step

Prevision Policy Clips | “Plausible Mechanism” Draft Guidance Is “Big Catalyst” For Encouraging Data Sharing