“All-Interchangeable” Biosimilar Policy Gains More Support In Drug Pricing Debate; FDA Says Proposal Is Aimed At “Simplifying” Pre-Market Expectations

Prevision Policy Clips | CBER Gene/Cell Therapy Office Listening Session On “Leveraging Knowledge” Set For Sept. 18

CDER Highlights Successes Of Selective Safety Data Collection In White Paper; Signal That Push Toward “Pragmatic” Trials Will Continue In New Era At FDA

Prevision Policy Clips | CDER White Paper On Selective Safety Data Collection

Prevision Policy Clips | CDER Director Tidmarsh Praises “Quality And Integrity” Of FDA Staff

FDA “Commissioner’s Voucher” Program Open For Submissions; CMO Prasad Will Lead Dedicated Review Team For Each “Winner,” Providing MFN Pricing Is One Way To Qualify

FDA Select Panel Questions Use Of SSRI Antidepressant Class In Pregnancy, Airs Arguments Against Pharmaceuticals For Depression In General

PTSD Is Not ALS: Psychopharm AdCom Agrees Single Successful Trial Is Not Adequate For Otsuka/Lundbeck’s Rexulti; New Trial Needed For Post-Traumatic Stress Disorder Claim

Prevision Policy Clips | Sarepta Halts Elevidys Shipments, Seeks “Collaborative, Science-Driven” Review Of Safety Issues

R&D Incentives: National Academy Report Urges Focus On Reimbursement, Not FDA, To Better Align Innovation With Disease Burden; Impact Unlikely To Be Large In Current Administration

CDER Director Is Former Horizon, La Jolla CEO Tidmarsh; Biotech Entrepreneur Has Embraced “MAHA” Agenda; First Test Of Outside Leadership For CDER In 40 Years

Prevision Policy Clips | Former Biotech CEO Tidmarsh Is New CDER Director

Part B Update Rules: CMS Proposes “Guardrails” For Service Fees; Plans Acquisition Cost Survey That Could Lead To 340B Payment Cuts In 2027

Novel Combination Regimens In Oncology: FDA Outlines Cases Where Sponsors Can Use External Data Rather Than Traditional Factorial Trials

GSK Blenrep ODAC Turns Into Bad Dream: Reapproval Bid Based On DREAMM-7/8 Trials Voted Down Due To Dose Issues, Lack Of US Subjects

Prevision Policy Clips | CDER Director Selection Is “Close,” Commissioner Makary Says

Real-Time Release Of CRLs Is FDA’s Goal, Commissioner Makary, CBER Director Prasad Affirm; Makary Reiterates Prediction Of “Record Year” For Drug Approvals In 2025

Prevision Policy Clips | FDA Commissioner Makary’s Voucher Program Would Promote “Pet Projects”

Otsuka/Lundbeck Rexulti For PTSD: FDA Wants Committee Vote On Whether Single Trial Can Support Approval With Uncertain Supportive Evidence; Leaves Opening For “Yes” Vote

Prevision Policy Clips | Direct-To-Consumer Advertising Targeted In Vaccine Injury Hearing

GSK Blenrep Reapproval Request: FDA Remains Concerned About Ocular Toxicity And Dose Selection; Potential Split Decision On Two Proposed Indications From ODAC?

Prevision Policy Clips | 60 NMEs In 2025? Commissioner Makary Suggests FDA Will Approve “At Least 20%” More

PDUFA VIII: Commissioner Makary Suggests Lower Fees Could Be One Goal, CEO “Listening Tour” Starts Focus On Communication, Predictability

Prevision Policy Clips | Commissioner’s Voucher As Incentive For Price Reductions? FDA Commissioner Makary

GDUFA IV Gets Underway: Makary Highlights Supply Chain Improvements During Kick-Off Meeting; Industry Asks For Continued Focus On Complex Generics