Prevision Policy Clips | PDUFA VIII Negotiations: FDA Proposes To Limit Small Business Waiver To US-Based Applicants, Rare Disease Hub To Take On More

NTAP Class Of 2027: Nine Drugs Apply For Enhanced Medicare Payment For FY 2027; Seven are Orphan Drugs, Five Are Regenerative Meds; Bristol Makes Second Attempt For Cobenfy

Testosterone Label Expansion Will Need “Strong Scientific Justification,” CDER’s Davis Says; Comments Temper Enthusiasm From FDA’s Hand-Picked Panel

Prevision Policy Clips | BIOSECURE Provisions Head To Senate, Guidance Expected In Mid-2026

PDUFA VIII User Fee Talks: FDA Steering Committee Has Small Handful Of Experienced Negotiators; Most Previous Participants Were RIFed Or Retired

CNPV Proof Of Principle? USAntibiotics Augmentin XR Re-Approval Still Leaves Many Unanswered Questions About New FDA Pathway

New Approach Methodologies In Pediatrics: First Step Is Following ICH Guidance, FDA Officials Say; Tools To Support Pediatric Safety Extrapolation Already Exist

Prevision Policy Clips | US Antibiotics’ Augmentin XR Is First “Commissioner’s National Priority Voucher” Approval

CBER “Key Officials” Update: Hollowed Out Leadership Illustrated By December Directory Posting; Five Of 21 Remaining “Key” Positions Are Vacant

Childhood Vaccine Overhaul? FDA’s Hoeg Pushes Denmark Model At ACIP, Trump Endorses Review: Half-Dozen Vaccines At Risk, Along With RSV MAbs

Prevision Policy Clips | CBER Office Of Therapeutic Products Acting Deputy Director Is Megha Kaushal

“Off-The-Shelf” CAR-Ts Could Qualify For Accelerated Approval, FDA Says In JAMA; Article Previews New “Framework” And Affirms FDA Enthusiasm For Future CAR-T Development

Single-Trial Mindset: FDA Guidance Update Will Seek To Shift “Default” Expectation For Drug Development; Impact May Not Be As Profound As It Sounds

Prevision Policy Clips | “Single-Trial” Standard To Be Outlined In Upcoming Guidance

Prevision Policy Clips | “Single-Trial” Standard Floated By FDA Commissioner Makary

Acting CDER Director Hoeg Says New Vaccine Policy Will Lead To More Frequent Labeling Changes; COVID Vaccine Pediatric Death Data Coming “Imminently”

Prasad’s FDA? Acting CDER Director Hoeg Is Ally Of CBER Director, Will Instill “Culture Of Cross-Center Coordination”; OTC Office Change May Be Sign Of Things To Come

Prevision Policy Clips | Acting CDER Director Hoeg Is Prasad Ally

Biosimilars Industry Pushes For Stability At FDA To Ensure Long-Term BsUFA Program Success; Praises Agency Staff, Policies To Streamline Development

Prevision Policy Clips | FDA After Pazdur: Uncertainty Looks Like A Fact Of Life For The Agency

Pazdur’s Last Stand? New CDER Director Reportedly To Retire At End Of December – But Door Still Open To Remain; Instability Likely Regardless

Reducing Animal Testing: FDA Proposes 3-Month Non-Human Primate Studies Can Suffice For MAbs; Opportunities To Waive NHPs Altogether

FDA Deadline Tracker: December Could Be Busy With 10 NME Decisions – And Potential First CNPV Approval(s); Agency Aiming For 50 NMEs In 2025

Advisory Committee Tracker: FDA Will Discuss Ways To Expand Access To OTCs In 2026; Advisory Committees Still MIA Under Makary

Prevision Policy Clips | Pediatric Priority Review Voucher Reauthorization Clears The House December 1