CLEAR LABELS Still Has Bipartisan Support, ANDA Priority Review Pilot To Support Domestic Manufacturing May Be In Play In 2027 GDUFA Negotiations

FDA Nominee Overton Leans Into China Biotech Rivalry, Promises To “Go Fast” On Drug Development Reforms; Hearing Showcases Challenges Ahead For Inexperienced Leader

Prevision Policy Clips | Sydnexis Appeal Of Ophthalmic Atropine Rejection Set For October 30 Advisory Committee Review

Generic GLP-1s Are “Urgent Public Health Need,” CDER’s Davis Says: Byetta/Victoza Show Agency Is Ready For Semaglutide/Tirzepatide; Compounding Is Not A Generic Substitute

Prevision Policy Clips | HHS Deputy Nominee Klomp Confirmation Vote In Finance Committee Set For September 24

FDA/CMS Pilot For Ultra-Rare Diseases? Former CBER Director Marks Urges Congressional Action, New Approaches To Advance The Field

Prevision Policy Clips | Surgeon General, SAMHSA Nominees Will Have Confirmation Votes In Senate HELP Committee

START Pilot Praised By Neurogene: “Warp Speed”-Style Communications Aided Launch Of Pivotal Trial; “Conviction” As Important As Time Saved, CEO Says

Prevision Policy Clips | “GENEROUS” Medicaid MFN Model Will Launch Nationwide

CMC Flexibility For Cell And Gene Therapies: No Magic Number Of PPQ Batches, FDA’s Schultz Tells ASGCT; “Generalist” Inspection Teams Still Include OTP Experts

Testosterone Use In Women: FDA Urges Sponsors To Try Again After Failures Two Decades Ago; Workshop Follows “Expert Panel” On Testosterone In Men

Prevision Policy Clips | CBER Acting Deputy Director Is Scott Steele, Vaccine Review Office Gets A Number Two

Industry Endorses GDUFA Agreement At Public Meeting: “Incremental” Changes Reflect Emphasis On Cost Containment

Oral Chemotherapy Hearing Focuses On Physician Reimbursement In Private Market More Than High Drug Prices; Big Topic Draws Small Attendance From Legislators

Interchangeability Guidance Update Planned By End Of FY 2028, FDA Says In BSUFA III “Strategy Document”; Report Calls Out Concerns About Biosimilar-Device Combos

FDA Responds To Pediatric Advisory Committee Concerns About AE Reporting, Highlights New Centralized Portal; Sprycel Interaction With Methotrexate Is Only New Signal

Prevision Policy Clips | HHS Deputy, Surgeon General Nominee Have Smooth Confirmation Hearing

PDUFA VIII Meeting Reinforces “America First” Theme; FDA Commits To “Maintain And Restaff Expertise” For Cell & Gene Therapy Reviews

CDER CRLs Have Been Trending Down Over Time, FDA Report Says, Though Novel BLAs Are An Outlier; Report Intended To Rebut Headlines About 2025 Rejections

Expedited IND Pilot Launches With 8-10 Candidates For Rolling Review To Be Selected By Mid-December; “Novel” Therapies, US-Based Trials To Be Prioritized

Prevision Policy Clips | Expedited IND Pilot Launches: FDA Sets October 30 Deadline For Applications

CMMI Cell And Gene Therapy Model Is Bipartisan Drug Pricing Success, CMS Advisor Says; Expanding Model Will Involve Finding Right Therapeutic Context

REMS For Therapeutic Psychedelics: Stakeholders Share Variety Of Opinions On Safety Requirements During Part 15 Hearing; Targeted Approach Urged

Prevision Policy Clips | CNPV Future Will Be Up To Next FDA Commissioner, Deputy Graham Indicates

“CoGenT” Gene Therapy Global Pilot Future Is Uncertain, But Collaborative Review Remains Possible; Parallel Scientific Advice Program Has Little Uptake