Prevision Policy Clips | Usona Institute CMO Mike Davis Named CDER Deputy Director; Former FDAer

Real-World Evidence Submissions To FDA: Three Product Applications Used RWE In FY2024

Prior Authorization Reform Pledge: Insurers Will Have “Real-Time Responses” For 80% Of Electronic Requests By 2027; HHS Applauds Voluntary Approach, Stresses Interoperability

Prevision Policy Clips | CDER’s Corrigan-Curay Announces Retirement As New Director Announcement Appears Imminent

Advisory Committee Tracker: Rexulti For PTSD And Blenrep’s Return Highlight FDA’s July Agenda – But Capricor DMD Therapy Vanishing Act May Be Biggest News

Prevision Policy Clips | House Appropriations Committee Will Resume FDA Funding Mark-Up Tonight

FDA Highlights Standardized Safety Data Presentation Tools Via MAPPs And New Website, Cites Potential To Streamline Reviews; Guidance By Other Means?

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened Scrutiny, FDA Says; No Disruption To Ongoing Treatment, But New Trials Must Have “Domestic” Handling

Prevision Policy Clips | FDA Cell And Gene Therapy Review Office Will Be Led By Vijay Kumar

Sanofi’s Tolebrutinib For Multiple Sclerosis Could Find “Niche” Market Among Established Drugs; Liver Monitoring Likely A Barrier To Uptake, ICER Panel Says

Cell And Gene Therapy Regulatory Uncertainty Spikes: OTP Director Verdun, Deputy Anatol Forced Out; Will Prasad’s New Role As “CMSO” Mean More FDA Disruption Ahead?

Fastest Reviews At FDA: “Commissioner’s Voucher” Timeline Is Not Unprecedented; Two Dozen NMEs Have Been Approved In Less Than Four Months – Since 1985

Prevision Policy Clips | HHS Budget Hearing In House Energy & Commerce/Health Subcommittee June 24

America First: “Commissioner’s National Priority Voucher” Promises “1-2 Month” Review For Select US Firms; Criteria Uncertain – As Are Potential Benefits

Prevision Policy Clips | Senate Reconciliation Bill Drops Orphan Drug Price Negotiation Fix

FDA Asked To Explain Apparent Increase In NDA Rejections By House Appropriators; COPD, DMD, HIE Among Diseases Highlighted For Special Attention In Approps Report

FDA Highlights Quantitative Medicine Contributions To Novel Approvals In Office Of Clinical Pharmacology Annual Report

Prevision Policy Clips | Sarepta Suspends Shipment Of Elevidys Gene Therapy For Non-Ambulatory Patients

FDA Sees New Paradigms For Rare Disease Trials: Focus On Early-Stage Patients, Shift Away From Adults-First Approach; “HUB” Sets First RISE Meeting On Control Arms

Prevision Policy Clips | A Way Back For Blenrep? ODAC Review For GSK’s Multiple Myeloma Drug Is July 17

Generics Industry “Heartened” By FDA Rehirings; E&C Hearing Spotlights Economic Challenges With Onshoring Generic Production

Prevision Policy Clips | RFK’s Handpicked ACIP Roster Includes Three Former FDA Advisory Committee Members

Super-STAR? FDA’s Makary Highlights Plans For “Real-Time” Reviews Across The Agency In JAMA, Presumably Building On PDUFA “STAR” Pilot Program

Prevision Policy Clips | FDA Priorities Under Makary: Shortening Time To Market For New Drugs, Using AI For Reviews

Prevision Policy Clips | MAHA Comes To ACIP: Purged CDC Vaccines Committee Will Replace 17 Existing Members