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

Prevision Policy Clips | Stealth Elamipretide Rejected By FDA After Extended Review, But Accelerated Approval May Be Path Forward

Advisory Committee Tracker: Three Rare Disease Drugs Are Headed To Advisory Committees, But FDA Has Yet To Announce Any Dates; Capricor DMD Cell Therapy Could Be As Early As June

Prevision Policy Clips | COVID-19 Vaccination Removed From Vaccine Schedule For Healthy Children And Pregnant Women

COVID Vaccine 2025-2026 Formula Will Be JN.1 Lineage, With Preference for LP.8.1 Strain: VRBPAC Members Question Impact of New Framework on Availability; FDA Has No Answers

Prevision Policy Clips | Biopharma CEOs Invited To Engage With FDA Leadership

UroGen’s Bladder Cancer Mitomycin Gel Gets ODAC Split Vote; FDA Expresses Concern About Low-Bar Precedent From Single-Arm Trial

FDA Talc Talk: “Expert Roundtable” Urges Cautious Approach on Talc – And Illustrates Echo-Chamber Regulatory Approaches Under Makary; Pharmaceuticals Have Largely Moved to Alternative Excipients

Prevision Policy Clips | FDA Advises COVID Vaccine Manufacturers To Use JN.1 Lineage With Specific Strain After Unanimous VRBPAC Vote

Drug Reviews Are “On Time,” FDA’s Makary Testifies; Missed Goal Dates Are Due To “Complexity,” Not Cuts; Proposed 11.5% Budget Cut “Will Not Fly,” Sen. Murray Declares

Organ-On-A-Chip: FDA “Roadmap” Doesn’t Clear All Obstacles For Animal Testing Alternatives, GAO Report Says; Upcoming Guidance Could Help, But Timeline Uncertain

OCE’s Pazdur Sinks Pfizer’s Talzenna In “All Comers” Prostate Cancer; New Trial Needed For “Huge” Indication Expansion

Prevision Policy Clips | FDA Acting OII Director Is Elizabeth Miller

J&J Darzalex Faspro Use In Smoldering Myeloma Supported By ODAC Despite Reservations About Over-Treatment; Will FDA And Sponsor Agree On “High Risk” Claim?