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Prevision Policy Clips | FDA Bayesian Analysis Draft Guidance Released, Fulfilling PDUFA Commitment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

Prevision Policy Clips | 340B Rebate Pilot Program On Hold After Federal Court Ruling

Medicare MFN Pricing Rules Unveiled: “GLOBE” And “GUARD” Would Turn Inflation Rebates Into Reference Pricing Tool; Impact Unclear In Light Of White House Deals

Prevision Policy Clips | CMS International Reference Pricing Rules Unveiled: “GLOBE” (Part B) And “GUARD” (Part D)