Fallen STAR: FDA “Split Real-Time Application Review” Pilot Has No Participants, Agency Cancels Planned Assessment; Will CNPV Model Take Over?

Prevision Policy Clips | Setting STAR: FDA “Split Real-Time Application Review” Pilot Has No Participants

Release The Review? FDA’s Thanh Hai Suggests Disclosure Of Full Memos For Rejected Products May Be More Useful Than CRLs Alone

Prevision Policy Clips | AbbVie Joins Industry Most Favored Nation Pricing Pledge

CBER Guidance Agenda Includes New Vaccine Documents As Prasad Readies To Formalize Policy Changes; “Plausible Mechanism” Guidance In The Works

Cell & Gene Therapy CMC “Flexibility” Highlighted By FDA; Another Informal Policy That Sounds Good To Sponsors – But Product Review Decisions Continue To Raise Doubts

Citizen Pazdur: Former FDA Oncology Chief Says He Has No Interest In Retirement, Starting To Plan Next Steps

FDA’s New RWE Approach: Device Guidance Checklist, Criteria On Reliability/Relevance Of Data Sources Are Likely To Be Adopted For Drugs/Biologics

Prevision Policy Clips | FDA Highlights Cell & Gene Therapy CMC “Flexibility” Ahead Of JP Morgan Conference

FDA Bayesian Statistics Guidance Stresses Need For Documentation To Support New Methods; Case Studies Include Oncology Platform Trials, CID Pilot Proposals

Prevision Policy Clips | FDA Bayesian Analysis Draft Guidance Released, Fulfilling PDUFA Commitment

FDA Advisory Committee Trends: A Record Low Year For Meetings In 2025; Uncertainty About The Process Overhangs 2026

Prevision Policy Clips | FDA Affirms Rejection Of Vanda’s Hetlioz Jet Lag Indication

Clinical Support Software Can Get Specific, FDA Says In Updated Guidance; Change Could Mean More Explicit Rx Recommendations; Wearables Also More Broadly De-Regulated

GDUFA IV Update: Inspections Are Key Early Theme; Industry Requests Include Review Tracking Portal, Improving ANDA Timeline Predictability

Prevision Policy Clips | FDA Broadens Regulatory Exemptions For Wearables, Some Clinical Decision Support Software

Advisory Committee Tracker: Dry January For FDA Advisory Committees; Few Opportunities To Hear Direct From Career Staff

Prevision Policy Clips | CDC Downgrades Flu, Rotavirus, Hepatitis A/B And Meningococcal Vaccines

PDUFA VIII Update: FDA Proposes No New Resources For Cell & Gene Therapies; Industry Proposes Bigger RWE Push, First-Cycle Review Changes

FDA Deadline Tracker: FDA Delivers Strong Approval Numbers For 2025, But Warning Signs Are Growing Heading Into 2026; Does “On-Time” Mean More CRLs?

Prevision Policy Clips | FDA GI Division Director Will Be Matthew Kowalik

The GLOBE List: 62 Products Identified By CMS As Potentially Subject To Reference Pricing Under New Model; Three-Quarters Are From Firms With White House Deals

Prevision Policy Clips | CDER Ends 2025 With 48 NME Approvals

Prevision Policy Clips | Where Are The CNPV Approvals?

CMS GLP-1 Demo Will Kickstart Part D Coverage For Weight Loss In July; Plan Will “BALANCE” Drug Access With Lifestyle Support; Will PDPs Sign On?