Accelerated Approval Beyond Oncology: Some Diseases May Not Fit Pathway Well; RWE Not Seen As Answer At NASEM Workshop

FDA’s OTC Paradigm Cannot Begin Until “ACNU” Rule Is Final; “Additional Condition For Nonprescription Use” Is Not “Third Class” In Disguise

Prevision Policy Clips | Senate Judiciary Committee Will Mark Up Pharma Bills

CMS And Accelerated Approval: Pricing Demos Under Discussion But “There Is No Simple Answer”; Aduhelm Policy Is “Unique Circumstance,” Agency Tells NASEM Workshop

Prevision Policy Clips | CBER Deputy Celia Witten Will Lead Office Of Therapeutic Products

Part D Out Of Pocket Cap Set At $8,000 For 2024 Before Benefit Re-Design Kicks In For 2025; Insulin, Adult Vaccine Co-Pays Spelled Out By CMS

The Competing Legacies Of Aduhelm: FDA Feels Vindicated, But Expanding Role Of Accelerated Approval Depends On Heeding Calls For More “Transparency”

Prevision Policy Clips | Senate Finance Chair Wyden Urges CMS To Move Quickly On Medicare Rx Inflation Rebate Invoices

Prevision Policy Clips | House Hearing Suggests Bipartisan Interest In Banning “QALYs” In Federal Payment Policy

Accelerated Approval Changes In FDORA Play Well At NASEM Workshop; FDA Planning Multiple Guidances, Says “Authority” In Statute Will Help With Confirmatory Trials

FDA External Controls Guidance: Controlling Time Issues Is Key To Use In Studies For Regulatory Submission; Next Chapter In FDA’s RWE Draft Guidance Portfolio

FDA Office Of Regulatory Affairs Role Will Change As Part Of Broader Restructuring Focused On Food Safety; Details TBD

Prevision Policy Clips | FDA's Califf Faces First GOP Oversight Hearing

Advisory Committee Tracker: FDA Has Busy Start To 2023; Agenda Includes ALS Drug, Two RSV Vaccines, Another Unusual ODAC And Opioid Response Topics

CBER Gene Therapy "Super Office" Transition Includes New Leadership: OTAT Director Wilson Bryan To Step Down In Coming Weeks

Prevision Policy Clips | CBER Gene Therapy Review Office Will Have New Director; Wilson Bryan Is Retiring In March

Prevision Policy Clips | Biopharma Congress Is Two Weeks Away On Feb. 13: CBER Director Peter Marks

TGT’s MS Agent Briumvi May Have Some Convenience Advantage Over Genentech’s Ocrevus, ICER Panel Says, But Low Value Versus Generic Tecfidera

FDA Wants More COVID-19 Manufacturers At The Table: “Simplified” Vaccine Campaign Will Help, CBER’s Marks Says

Prevision Policy Clips | Second Naloxone OTC Application Heads To Advisory Committee March 20

FDA Punts To Congress On CBD Regulation: “New Pathway” Debate Will Reinforce Likelihood That Broader Drug Regulatory Topics Stay Out Of Political Spotlight

Cidara/Melinta’s Rezafungin On Track To Be First “Limited Use” Antifungal After Positive Committee Vote; Once-Weekly Dosing Viewed As Clear Clinical Advantage

Prevision Policy Clips | House Democrats Establish Committee Membership with New Jersey’s Frank Pallone

Prevision Policy Clips | Another AA Review By ODAC: Genentech Polivy Will Be Reviewed March 9 For First Line Indication

Prevision Policy Clips | Makena Gets Closer To Forced Withdrawal: Presiding Officer Celia Witten Agrees With CDER, Hearing Outcome