Pfizer/Trump Drug Pricing Deal Suggests Template For Industry: MFN Price For Medicaid, Promise US Gets Lowest Launch Prices Going Forward; Details Remain Vague

Advisory Committee Tracker: VRBPAC Comes Back, But Product-Focused Advisory Committees Have Vanished

Prevision Policy Clips | CDER Director Tidmarsh Questions Aurinia Lupus Drug Lupkynis In LinkedIn Post About Surrogate Endpoints

FDA Shutdown Plan: Agency Would Keep 86% Of Post-RIF Workforce, Contingency Plan Says; NDA, BLA Reviews Continue, But New Filings Would Be Held Up

RWE In Regulatory Decision-Making: Engaged FDA Review Division, Hard Outcomes And Strong Registries Are Themes; Don’t Come To Us After A Failed Trial, Agency Says

Prevision Policy Clips | FDA Will Retain 86% Of Post-RIF Workforce In Shutdown

Connecting COAs To Clinical Meaningfulness Is Key: FDA PFDD Workshop Highlights Common Challenges In COA Development And Review

Prevision Policy Clips | CMS “Global Benchmark for Efficient Drug Pricing (GLOBE) Model” Proposed Rule Received

ARPA-H Launches Personalized Medicine Push: “THRIVE” Will Pursue Genetic Platforms Beyond AAV And CRISPR; “GIVE” Seeks Bedside Manufacturing For RNA Therapies

Cell & Gene Therapies Post-Approval Surveillance: FDA Highlights Registries, Decentralized Data Collection Over Other RWD Sources For Long-Term Follow-Up

Prevision Policy Clips | Dana-Farber’s Anthony Letai Expected To Be Named NCI Director

FDA Regenerative Medicine Expedited Programs Guidance Update Emphasizes QC, CMC Issues; Adds Thinking On Preliminary Clinical Evidence, Real-World Evidence

FDA’s Updated COA Dossier: Agency Expects Reduction In Information Requests, Faster Reviews; Drug Sponsors Are Cautiously Optimistic

Cell/Gene Therapy Innovative Trial Designs Include Using Patients As Their Own Control; One Of Six Options Recommended In FDA Draft Guidance

FDA Hiring Is Recovering, But Pace Is Not Back To Pre-RIF Levels, Agency HR Leaders Say; Centralized Model Will Benefit Agency In Long Run, They Maintain

Prevision Policy Clips | Innovative Trial Designs For Small Population Cell And Gene Therapies: FDA Draft Guidance

Prevision Policy Clips | Scholar Rock’s SMA Therapy Apitegromab Receives FDA CRL Due To Manufacturing Issues

FDA Safety Labeling Changes Guidance Update Adds “Reduced Effectiveness” As An Adverse Effect; New Draft Will Replace 2013 Final Guidance

Cell & Gene Therapy Sponsors Eager For More Guidance On “Platform” Approaches; OTP Listening Session Includes Ideas For “Platform Master Files,” “Joint BLAs”

Biosimilars Regulatory Standards “Update” Coming, CDER’s Tidmarsh Says; Future Model Will Be “Very Close To Generic Drugs”

Prevision Policy Clips | ACIP Tables Hepatitis B Vote; COVID Votes Appear Benign

Woodcock Unplugged: Ex-CDER Director Calls For New “Process Approval” Model For FDA, Warns Of “Backsliding” And “Circling The Wagons” In Review Teams

Prevision Policy Clips | FDA Senior Advisor To Commissioner Makary Is Former Enzyme CEO Jared Seehafer

Regulatory Approaches “Must Evolve” To Support Gene/Cell Therapies, OTP Acting Director Kumar Says; Leveraging Knowledge Across Programs Will Be Key Next Step

Prevision Policy Clips | VRBPAC Returns: 2026 Southern Flu Strain Selection Will Be One Topic Of October 9