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

Prevision Policy Clips | FDA Patient Engagement Advisory Committee Will Be Asked To Identify “Important Elements” In Informed Consent

RFK Declares War On FDA: Would Trump Really Let Him “Go Wild On Medicines”?

Pazdur Celebrates 25 Years At FDA With Former Commissioners: Next Agency Chief Should “Examine Your Internal Compass – And Stick To It,” Califf Says

Prevision Policy Clips | RFK Warns FDA: “Preserve Your Records” And “Pack Your Bags,”

Prevision Policy Clips | Methodological Challenges To Patient Experience Data: FDA Workshop Dec. 13

Rare Disease Reviews At FDA: Support For “Outside The Box” Thinking By Agency Showcased At NORD Meeting

IRA “Small Biotech” Exemption Expansion Is On GOP Post-Election Wish List; PRV Reauthorization “Challenging Enough” Without Revisions

Prevision Policy Clips | OCE’s Pazdur Celebrates 25 Years At FDA – But He’s Not Thinking Of Retirement: “I’m Just Beginning Here"

Prevision Policy Clips | RSV Vaccines For Use In Children: FDA Vaccines Committee Will Discuss

Prevision Policy Clips | CDER Prioritizing Regulatory Flexibility Under Rare Disease Program: Cross-Cutting Internal Teams

FDA Antiemetic Draft Guidance May “Facilitate” Registrational Trials For Drugs Used Off-Label For Postoperative Nausea/Vomiting Prophylaxis, Agency Says

OTC Contraceptive Coverage Policy Could Expand To Smoking Cessation Products – If Proposed Rule Carries Forward After Election Day