The “DOGE” Manifesto: Regulatory Rollback May Not Affect FDA Much Beyond LDTs; End Of Telework Could Be Tougher On Agency

Clozapine REMS Appears Headed for Removal: FDA Advisory Committee Says Blood Monitoring Documentation And Provider Education Requirements Are Not Necessary To Ensure Safe Use

Prevision Policy Clips | CMS “Is Stronger Than Ever” As Biden Administration Draws To A Close

We’re Not In Kansas Anymore: CMS Nominee Oz Brings Unpredictability To Medicare Program; Round 2 Of Drug Price Negotiations Will Be Early Anti-Corporate Test

Prevision Policy Clips | Trump Embraces Telehealth? TV’s “Dr. Oz” Is Choice For CMS Administrator

FDA Caught Between Kennedy And Conservative Courts: Three Thorny Issues Will Test Agency’s Ability To Face Institutionalized Second-Guessing In 2025 And Beyond

AZ Andexxa Confirmatory Trial Questioned By FDA: AdComm To Discuss Thrombosis Risk, Lack Of Long-Term Benefit; Additional Trial May Be Next Step

Prevision Policy Clips | FDA Commissioner Speculation: Ohio Republican Rep. Wenstrup Said To Be Interested

FDA’s Gene Therapy Primer: FAQ Draft Guidance Addresses Common Questions For Cell/Gene Therapy Development; Fulfills PDUFA Commitment

FDA Sentinel Safety System Adjusting To “Hard Truths” Of Budget Uncertainty; Focus Will Be Operations, Not New Initiatives, Going Forward

Lilly Product Reclassification Campaign Expands To siRNA; FDA “Biologics” Definition Could Be Key Theme In 2025

Prevision Policy Clips | Gene Therapy FAQs: FDA Releases Draft Guidance

Clozapine REMS Review: FDA Committee Will Decide If Program Can Be Pared Back – Or Eliminated – Given Experience During Decade Of “Enforcement Discretion”

Prevision Policy Clips | Through The Looking Glass: RFK Jr. Is Trump’s Pick For HHS Secretary

Through The Looking Glass: RFK Jr. Is Trump’s HHS Pick

Oligonucleotide Nonclinical Safety Assessments: FDA Draft Guidance Addresses “Unique Challenges” With Category, Including Risk Of Off-Target Binding

OS As A Safety Endpoint In Oncology: Simulations And Modeling May Be Key To Adding “Rigor” To Assessing Immature OS Data, FOCR Panelist Says

Prevision Policy Clips | CBER Director Peter Marks Resolute In Face Of RFK Jr. Vaccine Questions With AdComms A Possible Solution, Sounds The Alarm On Bird Flu

Prevision Policy Clips | Circulating Tumor DNA As Intermediate Endpoint In Oncology Trials: FDA “Very Encouraged”

“Project Pragmatica” May Gain Traction For Post-Marketing Studies, Including Trials Not Aimed At FDA, Oncology Sponsors Indicate During FOCR Meeting

FDA Mass Exodus? It’s Too Early To Measure Impact Of Trump’s Win On Staff, Califf Says; Offers Wish List For Next Commissioner

Prevision Policy Clips | Senate Health Committee Chair Likely—But Not Certain—To Go To Cassidy

“Lame Duck” Session Could Still Be Eventful For Biopharma; Initial Post-Election Read Is To Anticipate Short-Term CR Through March, Unless Trump Wants Clean Slate For 2025

Prevision Policy Clips | REMS Logic Models Useful for Drugs That Aren’t First-to-Market in a Class

Prevision Policy Clips | RFK Jr Would Clear Out Senior FDA Officials “In Certain Categories” Like Nutrition