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

Iterum’s Oral Sulopenem Likely To Receive Approval In Restricted uUTI Population Following Favorable Advisory Committee Discussion

Prevision Policy Clips | Medicare Drug Price Negotiation Is Briefly Mentioned In Presidential Debate

Refuse-To-File “Easily Correctable” Problems Added To Revised CBER SOPP; Document Says Center Will “Attempt To Rectify” Those Issues

CDER Quantitative Medicine “Center Of Excellence” Plans Repository Of Case Studies; Mission Emphasizes Education About QM Successes

Prevision Policy Clips | BIOSECURE Clears House September 9; 79 Democrats Vote “No”

Prevision Policy Clips | BIOSECURE Act Set To Pass House During “China Week”

Prevision Policy Clips | FDA Preparing To Expand “Integrated Review” Template To More Applications, Wants Feedback

Gene Therapy Transition From AAV Vectors To CRISPR-Edited Products Over The Next Decade Should Lower Costs And Expand Access, CBER’s Marks Predicts

Iterum’s Sulopenem Appears Headed To Approval: FDA Wants Public Discussion Of Warning Against Off Label Use Beyond Uncomplicated UTI

FDA Eager To “INTERACT” With Start-Ups: Webinar Emphasizes Range Of Meeting Opportunities, Enthusiasm Of Agency To Engage

Prevision Policy Clips | Stealth Bio Elamipretide For Barth Syndrome Set For Cardio-Renal Advisory Committee Review October 10

Prevision Policy Clips | FDA Updates Nitrosamine Guidance To Set August 1 Deadline For NDSRI Testing

Prevision Policy Clips | FDA Vaccines Office Deputy Is Karin Bok