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?

FDA Offers More Support For States Who Want To Import Drugs From Canada; “Pre-SIP” Meetings, Feedback In Fall Among Plans

Prevision Policy Clips | Trump Administration “In Negotiation” With Drug Companies Over MFN

FDA’s Two-Tier COVID “Framework” Unveiled: RCTs Required To Support Boosters In Young, Healthy Individuals, But Policy Does Not Extend To Other Vaccines

Columvi STARGLO Supplement Shot Down By ODAC; FDA Will Be Pressing Sponsors To Choose Optimal Control Arms For US Patients In Global Trials

MFN 2.0: HHS Sets Pricing Target To Lowest Price In An OECD Country; Trump Administration Wants Manufacturer Commitments “In Coming Weeks”

COVID Booster Meeting: FDA Releases Bare Bones Briefing Document Ahead Of May 22 VRBPAC; New “Framework” Mandates Randomized Trials In Future