Prevision Policy Clips | House Energy & Commerce Chair Will Be Kentucky Republican Rep. Guthrie

The Other Transition: GOP Takes Control Of Senate; Cassidy Will Be Key Figure For Biopharma In 2025, With Ample Turnover From Last GOP Majority

Prevision Policy Clips | Pharma’s “Middleman” Message Resonates With President-Elect Trump

Gene Therapy Follow Up Should Balance Need For Data Against Patient Burden: 15-Year Requirement “Starts To Replicate A Clinical Trial,” Bluebird Bio Exec Says

Accelerated Approval Guidance: Novel Endpoint Engagement Should Happen “Early”, Advisory Committee Review Prior To Withdrawal Decision Is “General” FDA Policy

Prevision Policy Clips | Califf’s Farewell To Capitol Hill? Senate HELP Committee Hearing On Food Regulation

FDA Streamlined Path For MDI Propellant Transition Encourages Sponsors To “Aim For” Bioequivalence Between New And Old Formulation; Long Term Safety Still Needed For Now

Metered-Dose Inhaler Propellant Transition: FDA Eager To Avoid Replay Of CFC-To-HFA “Complexity” – But Process Is Still Going To Be Challenging For Generics

Prevision Policy Clips | Accelerated Approval Draft Guidance Mandated By FDORA Updates Decade-Old Version, Separate Guidance Coming On Confirmatory Trial Timing

Prevision Policy Clips | Applied Therapeutics Warning Letter Explains CRL For Govorestat To Treat Galactosemia

House Coronavirus Subcommittee Report Targets CBER Director Marks’ “Sidelining” Of Vaccine Office Leadership In BLA Review

Prevision Policy Clips | FDA Announces Leadership For Drug, Biologics Inspectorates

FDA Guidances May Be More Standardized And Easier To Search, Agency Says In Final Report On “Best Practices”; “Direct-To-Final” Guidances Likely to Remain Rare

FDA’s “Best Practices For Communication”: Supporting Materials Will Regularly Accompany Important Agency Documents Going Forward, FDA Says In Draft Report

Advisory Committee Tracker: Ferring/Seikagaku Condoliase Herniated Disc Treatment Set To Kick Off 2025 Agenda; Another Quiet December

Prevision Policy Clips | Ferring/Seikagaku Condoliase Herniated Disc Treatment Heads To Advisory Committee In January

Prevision Policy Clips | Obesity Drug Coverage Rule Blasted By RFK Jr. Advisor Calley Means

The Politics And Policy Of Weight Loss Drug Coverage: CMS Coverage Proposal Will Test Incoming Trump Team; Is “Obesity” A Disease?

Prevision Policy Clips | CMS Weight Loss Coverage Rule Will Pose Early Test For Incoming Trump Administration

Atara/Fabre Tab-Cel Will Test Value Proposition For Allogenic Therapies: ICER Suggests $200,000 Per Cycle Could Be Cost-Effective; Payors See Coverage As “Relatively Straightforward”

Prevision Policy Clips | Hostile Takeover Of FDA? Commissioner Pick Martin Makary

FDA Commissioner Pick Makary Has Strong Views On Agency But Little First-Hand Knowledge; Has Criticized FDA Decision-Making And Work Ethic Around COVID

AZ Andexxa “Full” Approval Unlikely After FDA Committee Questions Confirmatory Trial Benefit; Accelerated Approval Status Seems Secure

OTCs At FDA: OMUFA II Will Show “True Promise” Of Monograph Reform; “Infrastructure” In Place Four Years Into New Program, “Innovation” Should Follow

Prevision Policy Clips | IPR Patent Board Reform Bill Advances In Senate, But Floor Vote Depends