Prevision Policy Clips | CBER AA For Rare Disease Gene Therapies Guidance Will Offer “Clear Expectations” On Data Required To Support Endpoints

Checkpoint Inhibitor Cut Points: ODAC Will Hear Case For Biomarker-Based Indications; Esophageal Relabeling May Be More Likely Than GI; Merck, Bristol, BeiGene To Present

Prevision Policy Clips | Rare Pediatric Disease Priority Review Voucher Reauthorization Bill Passes House

Medicaid Rebates: CMS Drops Price “Verification,” Rebate “Stacking” Proposals; “Misclassification” Policy Finalized Along With Other Technical Changes

Pertussis Challenge Models Are “Promising,” FDA Panel Agrees, But May Not Be Ready For Pivotal Efficacy Trials; Increasing Vaccination In Pregnancy May Be More Immediate Priority

Prevision Policy Clips | FDA Pediatric Voucher Program Would Be Extended To December 20 Under Continuing Resolution

Prevision Policy Clips | Patent Reform Bill Votes Postponed In Senate Judiciary Committee, Chair Dick Durbin (D-Ill.) Says

Re-Aligning R&D Incentives: CMS NTAP Program Offers Model For Encouraging Clinical Superiority Data, NASEM Committee Told

FDA Oncology Office Cautions Sponsors About Pitfalls Of Open-Label RCTs In Journal Article; Lumakras Is One Object Lesson

FDA Soft-Launching Advisory Committee Reform? Pediatric Advisory Committee Meeting Features New Format To Highlight Member Discussion

Prevision Policy Clips | VALID Act Passage During Congressional “Lame Duck” Session Urged By Sponsors

Senate Finance Chair Wyden Wants To Expand IRA Medicare Rx Measures To Private Sector, Crapo Solicits Reforms; PBM Bill In Lame Duck – Or Dead Duck?

Prevision Policy Clips | FDA Vaccines Advisory Committee Will Discuss Considerations For Avian Flu Vaccine Composition At October 10 Meeting

Prior Authorization Reform May Be Gaining Steam: CMS Proposed Rule Under Development; Mental Health Parity Rules Include Provisions That Will Impact PA And Step Therapy

A New Era Of Pragmatic Trials? FDA Guidance Offers Advice For Point-Of-Care Randomized Trials; New Uses Of Approved Drugs Are Favored Candidates

Continents, Not Countries: OCE Guidance On Global Trials Recommends Multi-Continent Approach To Address “Decreasing Proportions” Of U.S. Participants

Prevision Policy Clips | FDA RWE Lead John Concato "Transitioning To A Supportive Role" By Year-End

Intercept Ocaliva Appears Headed To Market Withdrawal After Negative AdComm; Real-World Test Of RWE Does Not Go Well For Sponsor

Prevision Policy Clips | Global Oncology Trials: FDA Guidance Offers Advice On Ensuring Applicability To US Population

FDA Advanced Manufacturing Strategy: Final AMT Guidance Coming Soon, CBER “CATT 2.0” Internal Procedures Under Revision, CDER ETP Guidance Update In 2026

Prevision Policy Clips | FDA Commissioner Califf Lauds Promise Of "Omics" Science But Stresses Need For "Oversight"

PBM Reform: Pending Proposals Viewed Skeptically By Academic Witnesses During House Hearing; Rare Voices Of Support For PBM Model On Capitol Hill

CDER Preparing To Expand “Integrated Review” Template To More Application Types, Wants Feedback On Possible Refinements To Documentation

Prevision Policy Clips | PBM Role Defended By Academic Witnesses

Oca-Leaving? Intercept Ocaliva Confirmatory Data in PBC Unpersuasive To FDA And Suggests Harm; Committee Vote Could Set Up “Streamlined” Withdrawal