Prevision Policy Clips | Democratic Roster For House Energy & Commerce Subcommittees: Health Subcommittee Ranking Member Will Be Colorado’s Diana DeGette

Ferring/Seikagaku Condoliase Approval Should Be Limited To Patients Who Fail Prior Radicular Pain Treatment, FDA Committee Says; Panel Predicts Overuse, But Majority See Benefits Outweighing Risks

COVID Vaccine Confidence Could Be Boosted By Placebo-Controlled Trials Of Next Booster, FDA’s Califf Says In Farewell Reflections

FDA Accelerated Approval Council Will Not Review Contested Applications: Center Leadership Will Continue To Be Decision Maker, Agency Says In Response To IG Report

Prevision Policy Clips | Orphan Drug Designation Program Overview, Guide To Formatting And Assembling Requests Are Among 2025 Draft Guidance Priorities

FDA Cell/Gene Therapy Review Update: CBER’s Marks Says Team Is Doing “Pretty Well” But Things Could Change In Transition; OTP’s Verdun Praised By Industry Group

CAR-T Warning “Refinements” Coming Soon, FDA’s Marks Says, With Autoimmune Uses To Follow; Next Focus May Be Changes To Reduce Treatment Burden

Prevision Policy Clips | Part D/MA Proposed Payment Update Notice Released By CMS, Along With Draft Instructions For Implementing IRA Changes

FDA Off-Label Promotion Policy Re-Set: “Final” SIUU Guidance Is Out, But Full Implementation Awaits OMB Action – And Trump; Legal Memo Warns Of Threat To Pre-Market Review Authorities

FDA Disruption Begins? CDER Director Cavazzoni To Depart Before Inauguration Day

Prevision Policy Clips | Otsuka/Lundbeck Rexulti PTSD Indication Faces Delay And Uncertainty After FDA Decides An Advisory Committee Review

Tissue Biopsy Guidance Emphasizes Special Considerations For Pediatric Trials; FDA Builds On Pediatric Ethical Considerations Guidance To Set “Direct Benefit” Standard

Prevision Policy Clips | FDA AI Policy Head Tala Fakhouri Joins CBER Director Marks, OCE Director Pazdur Feb. 24 At The Biopharma Congress

​​​​​Prevision Policy Clips | FDA Appears Ready to Approve Ferring/Seikagaku’s Condoliase But Wants To Ensure Appropriate Use

Ferring/Seikagaku’s Condoliase Advisory Committee Review Aims To Avoid Repeating History; FDA Appears Ready To Approve Radicular Pain Treatment But Wants To Ensure Appropriate Use

FDA Guidance Recommends Robust Characterization, Investigation Of Sex-Related Differences In Medical Product Research

FDA Draft Obesity Guidance Updated For GLP1 Era: Affirms Obesity As A “Disease,” But Keeps Primary Efficacy Requirements Largely Unchanged; CV Safety Expectations Outlined

Prevision Policy Clips | FDA Updating Obesity Drug Development Guidance For GLP-1 Era

AI In Drug Development: FDA “Credibility Assessment” Framework Emphasizes Context Of Use; Agency Wants Feedback On Whether Current Engagement Options Are “Sufficient”

The New Rules Of Accelerated Approval: FDA Draft Guidance Defines Standards For Assuring Confirmatory Trials Are “Underway”; Some Flexibility For Rare Diseases

Prevision Policy Clips | FDA Guidance Dump: 25 Guidances Announced January 6

Trump II Impact On FDA: Reviewers Will Feel Pressure Across The Board But Office Of Neuroscience, CBER May Face Most Impact; OCE Could Be Unscathed

FDA Advisory Committee Trends: Just 14 Applications Reviewed In 2024; Rejection Rate Also Goes Back Up From 2023

Prevision Policy Clips | CBER Plans Guidance On Post-Approval Safety And Efficacy Data For Cell/Gene Therapies

FDA May Accept “Similar” Submissions For Advanced Manufacturing Technology Designation Program, Final Guidance Says