FDA Deadline Tracker: Path To 60 NME Approvals Looks Steep; Two Rejected, One Delayed In August; Only Four On September Calendar

Prevision Policy Clips | NIH Funding Would Be Flat Under House Appropriations Bill

FDA Proposes “Product-Agnostic” External Control For Rare Pediatric Brain Tumor DMG/DIPG As Potential Model For Other Oncology Registries

Prevision Policy Clips | CDC Acting Director Will Be HHS Deputy O’Neill

COVID Vaccine Updates: Sponsors Agree To Study Possible Link Between Vaccination And Long COVID Following Strain Update; CBER’s Prasad Suggests Goal Is Reassurance

Oncology Registries: FDA Eager To See Field Advance; August Workshop Is “Kick Off” For Longer Process

Prevision Policy Clips | CDC Leadership In Turmoil: HHS, White House Say CDC Director Monarez Has Been Fired

Prevision Policy Clips | FDA Neuroscience Office Changes: Laura Jawidzik Is Leading Division Of Neurology 2

FDA Hiring And Retention Report Stresses Importance Of Telework; Pre-Trump Administration Data Find Low Attrition, High Satisfaction

Prevision Policy Clips | Osivax Influenza A Vaccine Receives $19.5 Million BARDA Grant

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