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Oligonucleotide Nonclinical Safety Assessments: FDA Draft Guidance Addresses “Unique Challenges” With Category, Including Risk Of Off-Target Binding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

Trump II: People To Watch And Key Questions For Biopharma During The Upcoming Transition

Prevision Policy Clips | IRA Repeal A Possibility If Republicans Sweep By Taking The House, Following Trump's Victory

Prevision Policy Clips | FDA Expands STAR Real-Time Review Pilot: Novel Applications May Be Submitted For Program Participation Dec. 2

Medicare Rx Inflation Rebate Rule Finalized, But 340B Exclusion Still Unsettled; CMS Working On Claims Data Repository That Could Help For Negotiated Pricing Too

Prevision Policy Clips | Former FDLI Head Rick Takes Top Post In FDA Rare Disease “Hub”

Lexicon Sotagliflozin For T1 Diabetes Haunted By DKA Risk In FDA Adcomm Halloween Sequel: Panel Spooked By “Uncertainty,” But Can Sota Be Resurrected?

Optimus For Orphans? FDA Officials Say Dose Optimization For Rare Diseases Should Not Be Sacrificed To Speed Access During Duke-Margolis Workshop

Prevision Policy Clips | FDA’s CDER Publishes Landing Page On AI In Drug Development

Informed Consent Should Discuss Risks Of Standard Of Care, FDA’s Califf Suggests; Patient Committee Supports “Key Info” Approach, But Streamlining Won’t Be Easy

Prevision Policy Clips | RFK Is “Not Getting A Job At HHS,” Trump Transition Co-Chair Lutnick Says – But Anti-Vaccine Message

Prevision Policy Clips | Congressional Research Service “In Focus” Document On Gene Therapies For Blood Disorders

Fork In The Road Or Dead End? Lexicon Attempts Final Appeal For Sotagliflozin With Post Hoc Analyses, Revised Diabetes Population With CKD

Advisory Committee Tracker: AZ Andexxa Is Latest Accelerated Approval Under Further Review; Anticoagulant Reversal Drug Risk/Benefit May Be In Doubt