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 $25 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”

Prevision Policy Clips | CDER “Meeting Minute Clarification Opportunity” Pilot Program

AI In Regenerative Medicine: Lack Of Training Data Is Obstacle To Advancing AI Use For Drug Development, CBER’s Oh Suggests; Manufacturing Is Focus For Early Adopters

Prevision Policy Clips | Where Are The IRA Prices? Senate Democrats Push For Publication Of Negotiated Prices

Prevision Policy Clips | US Generic Firms Will Testify At Senate Supply Chain Hearing November 19

Prevision Policy Clips | Sarepta Elevidys Relabeling Removes Non-Ambulatory Indication, Adds Black Box And Medication Guide

OCE Model May Expand To Other Areas, FDA’s Prasad Says During “Praise Pazdur” Edition Of Leadership Podcast; Makary, Prasad Affirm Support For Surrogate Endpoints

Prevision Policy Clips | Liver Safety Biomarker GLDH Qualified By FDA

Pazdur’s Welcome Letter To CDER Staff: “I Am Not A Micromanager”

Prevision Policy Clips | “Plausible Mechanism” Pathway Outlined By FDA Leadership

“Plausible Mechanism” Pathway Could Use “Regular” Approval Based On Evidence; RWE Will Be Key To Post-Market Surveillance, FDA NEJM Piece Says

FDA’s Makary Cites “New Workflow” Of CNPVs For Choosing Already Approved Products For Second Batch Of Pilot Program