CMS “Fit-For-Purpose” RWE Guidance Includes Template For Study Protocols; Intended For Devices But Could Be Expanded To Drugs—If Administration Agrees

Prevision Policy Clips | It’s (Almost) Official: Sara Brenner Is Now FDA Principal Deputy Commissioner

BsUFA Regulatory Science Pilot Seeking Partners For Human Factors Research; Interim Report Coming Before Planned September Meeting; Update Event Happens Despite Communications Freeze

FDA Diversity Action Plans In Limbo, OCE “Project Equity” Webpage Goes Dark As Trump Executive Order On DEI Takes Effect

Prevision Policy Clips | HHS Confirmation Hearing Set For January 29: Robert Kennedy’s

“Acting” FDA Commissioner Brenner Brings Trump White House-Level COVID Response Experience, Expertise In Nanoscience To Interim Role

Prevision Policy Clips | Communication Blackout At FDA Amid Transition

Prevision Policy Clips | HHS Acting Head Is Dorothy Fink; FDA Leadership Still Unannounced

Price Negotiation Class Of 2027 Includes Four Oncologic Agents; GSK, AbbVie, BI And Pfizer Have Multiple Products Selected; Ozempic Is The Headliner

Prevision Policy Clips | GSK, BI, AbbVie and Pfizer Each Have Two Drugs Up For Negotiation In Year 2

FDA Rare Disease Hub “Policy & Portfolio Council” Is First Step In CBER/CDER Coordination; Hub Agenda For 2025 Includes Three Scientific Workshops

Prevision Policy Clips | FDA Draft Guidance On Peripheral Neuropathy Associated With Chemotherapy

Gene Therapy Policy Opportunities Under Trump: Will Sector Fit Well In “MAHA” Agenda?

FTC Keeps The Heat On PBMs With Second “Interim” Report; Unanimous Vote By FTC May Be More Significant Than Modest Cost Impact From “Specialty” Generic Pricing

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Policy Clips | Orphan Drug Designation Program Overview, Guide To Formatting And Assembling Requests Are Among 2025 Draft Guidance Priorities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