Advisory Committee Tracker: Opioid Response Is Early 2025 Focus For FDA; Novartis Fabhalta sNDA Set For February Review

CMS Seeking “More Concise” Submissions For New Technology Add-On Payment Candidates; FY 2026 Cycle Kicks Off With 13 Drug/Biologic Products Seeking Enhanced Medicare Payment

Prevision Policy Clips | FDA “Point/Counterpoint” Draft Guidance Suggests Sponsors Can Decide

FDA Protocol Deviation Draft Guidance Urges Patient-Friendly Trial Designs To Minimize Deviations, Offers Examples Of “Important” Deviations

ODAC “Point/Counterpoint” Shared Briefing Document Formalized Via Draft Guidance; FDA Indicates Sponsor Chooses Approach, Invites Requests For Non-Oncology Products

Prevision Policy Clips | FDA Finalizes Advanced Manufacturing Technology Designation Program Guidance

“ACNU” Nonprescription Drug Safe Use Rule Finalized By FDA; Simultaneous Rx Marketing Would Be Permitted, If Rule Survives Trump Transition And Judicial Review

Prevision Policy Clips | FDA Shutdown Averted, But Pediatric PRV Program In Limbo

Prevision Policy Alert: FDA Shutdown Averted, But Pediatric PRV Program In Limbo

Prevision Policy Clips | Government Shutdown Clock Is Ticking: House Again Fails To Pass A Continuing Resolution

FDA Drug Shortage Provisions Left Out Of Proposed PAHPA Reauthorization Plan; “Lame Duck” Uncertainty Jeopardizes Prospects For Program

Prevision Policy Clips | “Lame Duck” Reset: Trump, “DOGE” Torpedo Bipartisan Continuing Resolution

Commissioner Califf’s Message On Setting R&D Priorities: Leave FDA Out Of It; National Academy Event Is Forum For Outgoing Commissioner To Reflect, Reiterate Key Themes

Prevision Policy Clips | Principal Deputy Commissioner Bumpus Leaving FDA at End of Year

End-Of-Year Christmas Tree: SUPPORT, PAHPA And PRV Reauthorizations Make It Into Spending Bill; PBM Reforms Include “De-Linking” Policy, “100%” Rebate Passthroughs

Patient Experience Data Needs More Thoughtful Consideration By Sponsors, FDA Says: Workshop Offers Advice On How To Use Available Methods

Prevision Policy Clips | HHS Nominee Robert F. Kennedy Jr. Goes To Capitol Hill This Week

RSV Pediatric Vaccine Research Should Continue Despite Moderna Setback, “Long Shadow” Of Safety Fears, FDA Committee Agrees; Sanofi May Have Best Prospects

Prevision Policy Clips | SUPPORT Act, PAHPA Reauthorizations And PBM Reforms

Prevision Policy Clips | Intercept’s Ocaliva Liver Safety Warning From FDA Is Latest Step Short Of Withdrawal

CDER’s Newest Sub-Center: Center for Real-World Evidence Innovation (CCRI) Aims To Promote “Efficiency And Consistency” On RWE Policy

FDA In “First Stages” Of Reconsidering Black Box For Antipsychotics In Dementia-Related Psychosis; Nuplazid and Rexulti Are Focus Of Discussions

Prevision Policy Clips | Lilly CEO Ricks Says Trump Administration Will Push Policy To Raise Drug Prices Abroad

GenAI: FDA Would Like To Work With Collaborative Groups On Access To Foundational Data; Clinical Outcome Benefits Remain Key

Prevision Policy Clips | GLP-1 Agonist Value Extolled By Elon Musk