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

Primary Mitochondrial Diseases Likely Require RCTs, But FDA Can Be Flexible On Endpoints And Designs, Agency Suggests During Reagan-Udall Workshop

Prevision Policy Clips | Onshoring Health Product Manufacturing Will Be Focus Of House Hearing June 11

Prevision Policy Clips | House FDA Appropriations Bill Follows White House Lead: $300 Million Cut

FDA Cell And Gene Therapy Roundtable Panelists Advocate For Onshoring Early Clinical Trials; OTP Leadership Praised Widely

FDA Opening The Archives: “Redacted” Documents Will Be Made Public, CBER’s Prasad Says; Real-Time Review Coming To More Classes?

AI And Generic Drugs: FDA Will Showcase Tool To Help Calculate Maximum Daily Dose; Agency’s Lionberger Stresses Big Returns From Investment In Generic Drug Science

Prevision Policy Clips | Sarepta Receives Platform Technology Designation For Gene Therapy Viral Vector

“ACNU” OTC Final Rule Highlighted In Senate Hearing: HELP Chair Cassidy Wants More Switches; Corrigan-Curay Handles First Hearing As Acting CDER Director

Prevision Policy Clips | Makary’s “Philosophy” For FDA Management Will Be Fleshed Out In Upcoming JAMA Article

Platform Technology Approvals Coming Soon? CBER’s Prasad Underscores FDA’s Continued Commitment To Program Under New FDA Leadership

The Case For Patient-Centered Artificial Intelligence: Former CDER Director Woodcock Sees Broad Uses For AI, If Models Are Aimed Correctly

FDA Deadline Tracker: Nucala COPD Approval Comes Two Weeks Late; Stealth Overdue Barth Drug Rejected

Prevision Policy Clips | FDA Rolls Out “Elsa” AI Tool: Industry Data Is Not Being Used To Train

CDER Staff Would Be Cut By 1,200 Under White House Budget, CBER Would Lose 260 Positions; Cuts Include User Fee Funded Slots

MAHA Report Directs FDA/NIH To “Independently Replicate” Industry Pediatric Trials; Kennedy Talking Points About “Overprescribing” Fleshed Out – But Undermined By Fictitious Citations

Prevision Policy Clips | CBER Appropriations Would Be Slashed 24%, CDER By 18% Under White House Budget Proposal

Repurposed Generics For Rare Diseases: Citizen Petition Process Could Jumpstart New FDA Pathway, Former CDER Director Woodcock Suggests

Prevision Policy Clips | Neuromuscular Disease Real World Data Collaboration Between Critical Path Institute and Citizen Health