Advisory Committee Tracker: Biohaven Troriluzole No Longer Going To Panel As Meeting Drought Continues; HHS Launching New “Federal Healthcare” Cmte.

Prevision Policy Clips | Valneva Ixchiq BLA Suspended By FDA In Abrupt Reversal

Prevision Policy Clips | FDA Commissioner’s Voucher Update: Review Divisions Picking Candidates, First Batch To Be Announced “Very Soon”

Emerging Trends In Pragmatic Trials: TransCelerate Summary Of FDA Trial Innovation Exercise Underscores Importance Of Patient-Centricity; C3TI “STEP” Pilot Highlighted

Prevision Policy Clips | Former FDA Commissioner Stephen Hahn Joins Nucleus RadioPharma As CEO

Prevision Policy Clips | User Fee Financial Transparency Meeting Set For September 30

FDA Oncology Therapeutic Radiopharmaceutical Dosage Optimization Guidance Includes Strategies To Handle Delayed Toxicities, Patients With Previous Radiation Therapy

OS In Oncology: Pivotal Trials Should Include Plans To Rule Out Harm When Survival Is Not The Endpoint, FDA Says; Accelerated Approval Is Option To Address Uncertainty

Prevision Policy Clips | FDA Will Present Updated COA “Evidence Dossier” Template At Sept. 18-19 Workshop

Prevision Policy Clips | Kennedy Plays Defense: HHS Secretary Says “The Swamp” Out To “Drive A Wedge” Between MAHA And Trump

Prevision Policy Clips | Prasad Speaks: “Randomized Trials Are Not Always Needed” For FDA Approval

White House EO On APIs Directs ASPR To Create “Most Critical Medicines,” Update “Essential Medicines” Lists

Prevision Policy Clips | FDA Has Received “A Great Deal Of Interest” In Commissioner’s Priority Voucher: Assessments Will Be Made “On A Rolling Basis”

Scholar Rock’s Apitegromab Misses The Mark At ICER’s SMA Review Meeting; Panel Overwhelmingly Finds A Lack Of Evidence For Add-On Therapy After Zolgensma

Prevision Policy Clips | CBER Org Chart Update Shows Vinay Prasad As CBER Director; OTP Yet To Recover From Deterioration

Prevision Policy Clips | USPTO Signals Reluctance To Take Administrative Action On Patent Reform, Warns Against Overregulation In FTC/DOJ Drug Pricing

Drug Quality Assurance Inspections Are Closer To Pre-Pandemic Levels, But Still Behind; China Leads Jump In Foreign Sites, CDER Report Finds

FTC/DOJ On Drug Pricing: “Balance” Needed Between Patent Rights And Reforms; USPTO Warns Against Overregulation In Final Listening Session

Prevision Policy Clips | Vinay Prasad’s Return To FDA: Move Signals Continued Volatility At Agency; A Fragile Stability Could Be Best-Case Scenario

Prasad’s Return To FDA Puts Center Consolidation Plan On Back Burner (Again), But Does A Window Remain Open For OCE 2.0?

Makary’s Prodigal Son Returns: Prasad’s Rebound At FDA Underscores Continued Volatility At Agency; Will A Fragile Stability Emerge?

Prevision Policy Clips | FDA Commissioner Makary On Lessons Learned From CEOs: "They Want Better Communication"

FDA “PreCheck” Domestic Manufacturing Proposal Features Pre-Operations Phase 1, Phase 2 To Offer “Advanced Awareness” Of Strategies For Specific Drugs

Prevision Policy Clips | Onshoring Drug Manufacturing: FDA To Present “PreCheck” Framework At Public Meeting Sept. 30

Bristol’s Persistence In Pursuing Breyanzi NTAP Wins CMS Acceptance For Two Indications; CMS Grants Seven New Drug Add-On Payments For FY2026