Prevision Policy Clips | “Single-Trial” Standard Floated By FDA Commissioner Makary

Acting CDER Director Hoeg Says New Vaccine Policy Will Lead To More Frequent Labeling Changes; COVID Vaccine Pediatric Death Data Coming “Imminently”

Prasad’s FDA? Acting CDER Director Hoeg Is Ally Of CBER Director, Will Instill “Culture Of Cross-Center Coordination”; OTC Office Change May Be Sign Of Things To Come

Prevision Policy Clips | Acting CDER Director Hoeg Is Prasad Ally

Biosimilars Industry Pushes For Stability At FDA To Ensure Long-Term BsUFA Program Success; Praises Agency Staff, Policies To Streamline Development

Prevision Policy Clips | FDA After Pazdur: Uncertainty Looks Like A Fact Of Life For The Agency

Pazdur’s Last Stand? New CDER Director Reportedly To Retire At End Of December – But Door Still Open To Remain; Instability Likely Regardless

Reducing Animal Testing: FDA Proposes 3-Month Non-Human Primate Studies Can Suffice For MAbs; Opportunities To Waive NHPs Altogether

FDA Deadline Tracker: December Could Be Busy With 10 NME Decisions – And Potential First CNPV Approval(s); Agency Aiming For 50 NMEs In 2025

Advisory Committee Tracker: FDA Will Discuss Ways To Expand Access To OTCs In 2026; Advisory Committees Still MIA Under Makary

Prevision Policy Clips | Pediatric Priority Review Voucher Reauthorization Clears The House December 1

PDUFA VIII: FDA Wants STAR Real-Time Review Phaseout, Industry Seeks First-Cycle Review Enhancements; Domestic Drug Development Fee Incentives Discussed

FDA Vaccine Guidance Rewrite Coming, CBER Director Prasad Declares; Higher Bar For Expanded Populations, Use In Pregnancy Among Changes Ahead

Prevision Policy Clips | FDA Vaccine “Mission…Will Change,” CBER Director Prasad Declares

Negotiated Prices For Class Of 2027 Average 36% Below Current Net Prices, CMS Says; Novo Semaglutide “MFN”’ Price Is $29 Below Medicare Negotiated Rate

Prevision Policy Clips | CMS Releases Second Set Of Negotiated Prices, Claims Net Cut Of 36%

“Data Fidelity” Among Initial FDA GDUFA Negotiation Themes, Onshoring Has Parallel Momentum In Congress; All Proposals Remain “On The Table”

Prevision Policy Clips | CBER Research Purge? Prasad Email To Staff Suggests Major Changes Ahead

FDA “Process” Approvals Urged By Advocates To Complement “Platform” Pathway For “N-Of-1” Therapies; Assumptions Behind ASO Guidance Not All Correct, FDA Acknowledges

Non-Opioid Pain Incentive In Medicare Will Not Apply To Vertex’ Journavx, CMS Affirms In Final Hospital Outpatient Rule; FDA Labeling Polices Are One Factor Limiting Eligibility

Prevision Policy Clips | FDA Leadership Drama Continues To Make Headlines

Where Are The Bespoke Breakthroughs? FDA Not Seeing Dramatic Efficacy From “N-Of-1” Treatments To Date; “Baby KJ” Is The Exception, Not The Rule

ICER Panel Reaffirms Cost-Effectiveness Of GLP-1 Weight Loss Agents; Budgetary Impact Still An Issue, Even At New Medicare Pricing, ICER Staff Suggests

“N-Of-1” Taking Off: CDER Has Cleared 49 Bespoke INDs, With Number Likely To Soar In 2026; CDER/CBER Coordinating, But Differences Will Remain For Gene-Editing Vs. ASOs

Prevision Policy Clips | FDA “Plausible Mechanism” Pathway Is Still “Under Construction”