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Prevision Policy Clips | Principal Deputy Commissioner Bumpus Leaving FDA at End of Year
December 18, 2024
End-Of-Year Christmas Tree: SUPPORT, PAHPA And PRV Reauthorizations Make It Into Spending Bill; PBM Reforms Include “De-Linking” Policy, “100%” Rebate Passthroughs
December 18, 2024
Patient Experience Data Needs More Thoughtful Consideration By Sponsors, FDA Says: Workshop Offers Advice On How To Use Available Methods
December 17, 2024
Prevision Policy Clips | HHS Nominee Robert F. Kennedy Jr. Goes To Capitol Hill This Week
December 17, 2024
RSV Pediatric Vaccine Research Should Continue Despite Moderna Setback, “Long Shadow” Of Safety Fears, FDA Committee Agrees; Sanofi May Have Best Prospects
December 16, 2024
Prevision Policy Clips | SUPPORT Act, PAHPA Reauthorizations And PBM Reforms
December 16, 2024
Prevision Policy Clips | Intercept’s Ocaliva Liver Safety Warning From FDA Is Latest Step Short Of Withdrawal
December 13, 2024
CDER’s Newest Sub-Center: Center for Real-World Evidence Innovation (CCRI) Aims To Promote “Efficiency And Consistency” On RWE Policy
December 12, 2024
FDA In “First Stages” Of Reconsidering Black Box For Antipsychotics In Dementia-Related Psychosis; Nuplazid and Rexulti Are Focus Of Discussions
December 12, 2024
Prevision Policy Clips | Lilly CEO Ricks Says Trump Administration Will Push Policy To Raise Drug Prices Abroad
December 12, 2024
GenAI: FDA Would Like To Work With Collaborative Groups On Access To Foundational Data; Clinical Outcome Benefits Remain Key
December 11, 2024
Prevision Policy Clips | GLP-1 Agonist Value Extolled By Elon Musk
December 11, 2024
Prevision Policy Clips | House Energy & Commerce Chair Will Be Kentucky Republican Rep. Guthrie
December 10, 2024
The Other Transition: GOP Takes Control Of Senate; Cassidy Will Be Key Figure For Biopharma In 2025, With Ample Turnover From Last GOP Majority
December 9, 2024
Prevision Policy Clips | Pharma’s “Middleman” Message Resonates With President-Elect Trump
December 9, 2024
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
December 6, 2024
Accelerated Approval Guidance: Novel Endpoint Engagement Should Happen “Early”, Advisory Committee Review Prior To Withdrawal Decision Is “General” FDA Policy
December 6, 2024
Prevision Policy Clips | Califf’s Farewell To Capitol Hill? Senate HELP Committee Hearing On Food Regulation
December 6, 2024
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
December 6, 2024
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
December 6, 2024
Prevision Policy Clips | Accelerated Approval Draft Guidance Mandated By FDORA Updates Decade-Old Version, Separate Guidance Coming On Confirmatory Trial Timing
December 5, 2024
Prevision Policy Clips | Applied Therapeutics Warning Letter Explains CRL For Govorestat To Treat Galactosemia
December 4, 2024
House Coronavirus Subcommittee Report Targets CBER Director Marks’ “Sidelining” Of Vaccine Office Leadership In BLA Review
December 3, 2024
Prevision Policy Clips | FDA Announces Leadership For Drug, Biologics Inspectorates
December 3, 2024
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
December 2, 2024
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