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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Prevision Policy Clips | Accelerated Approval Draft Guidance Mandated By FDORA Updates Decade-Old Version, Separate Guidance Coming On Confirmatory Trial Timing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
FDA’s “Best Practices For Communication”: Supporting Materials Will Regularly Accompany Important Agency Documents Going Forward, FDA Says In Draft Report
December 2, 2024
Advisory Committee Tracker: Ferring/Seikagaku Condoliase Herniated Disc Treatment Set To Kick Off 2025 Agenda; Another Quiet December
December 2, 2024
Prevision Policy Clips | Ferring/Seikagaku Condoliase Herniated Disc Treatment Heads To Advisory Committee In January
December 2, 2024
Prevision Policy Clips | Obesity Drug Coverage Rule Blasted By RFK Jr. Advisor Calley Means
November 27, 2024
The Politics And Policy Of Weight Loss Drug Coverage: CMS Coverage Proposal Will Test Incoming Trump Team; Is “Obesity” A Disease?
November 26, 2024
Prevision Policy Clips | CMS Weight Loss Coverage Rule Will Pose Early Test For Incoming Trump Administration
November 26, 2024
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”
November 25, 2024
Prevision Policy Clips | Hostile Takeover Of FDA? Commissioner Pick Martin Makary
November 25, 2024
FDA Commissioner Pick Makary Has Strong Views On Agency But Little First-Hand Knowledge; Has Criticized FDA Decision-Making And Work Ethic Around COVID
November 24, 2024
AZ Andexxa “Full” Approval Unlikely After FDA Committee Questions Confirmatory Trial Benefit; Accelerated Approval Status Seems Secure
November 22, 2024
OTCs At FDA: OMUFA II Will Show “True Promise” Of Monograph Reform; “Infrastructure” In Place Four Years Into New Program, “Innovation” Should Follow
November 22, 2024
Prevision Policy Clips | IPR Patent Board Reform Bill Advances In Senate, But Floor Vote Depends
November 22, 2024
The “DOGE” Manifesto: Regulatory Rollback May Not Affect FDA Much Beyond LDTs; End Of Telework Could Be Tougher On Agency
November 21, 2024
Clozapine REMS Appears Headed for Removal: FDA Advisory Committee Says Blood Monitoring Documentation And Provider Education Requirements Are Not Necessary To Ensure Safe Use
November 21, 2024
Prevision Policy Clips | CMS “Is Stronger Than Ever” As Biden Administration Draws To A Close
November 21, 2024
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