MFN Pledges Are Now Industry-Wide Standard: All 17 Firms Targeted By Trump Have Reached Agreements; Trump Sounds Ready To Turn The Page

Prevision Policy Clips | MFN Pricing Deals Delay Apparent Plan To Overhaul Vaccine Schedule

BIOSECURE Set To Become Law: OMB Will Take Lead On Listing Biotechs “Of Concern” But It Could Be 2029 Before Prohibitions Take Effect

Prevision Policy Clips | Angelo de Claro Named Oncology Center Of Excellence Acting Director

OTC Epipen? FDA Open To Switching Epinephrine For Anaphylaxis; Naloxone May Be One Model, ACNU Could Help; New Rx Formulations Also Encouraged

Prevision Policy Clips | CDC Adopts New Hepatitis B Vaccine Birth-Dose Recommendation

Prevision Policy Clips | De-Identified Data Can Be Included In RWE Submissions, FDA Declares; Applies Only To Devices At First

Diversity Action Plan References Deleted From Updated Guidances Posted By FDA; 2020 Trial Diversity Guidance No Longer References “Diversity,” But Advice Remains The Same

Prevision Policy Clips | FDA Finalizes Safety Reporting Guidances For Sponsors And Clinical Investigators

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

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”