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Accelerated Approval Beyond Oncology: Some Diseases May Not Fit Pathway Well; RWE Not Seen As Answer At NASEM Workshop
February 7, 2023
FDA’s OTC Paradigm Cannot Begin Until “ACNU” Rule Is Final; “Additional Condition For Nonprescription Use” Is Not “Third Class” In Disguise
February 7, 2023
Prevision Policy Clips | Senate Judiciary Committee Will Mark Up Pharma Bills
February 7, 2023
CMS And Accelerated Approval: Pricing Demos Under Discussion But “There Is No Simple Answer”; Aduhelm Policy Is “Unique Circumstance,” Agency Tells NASEM Workshop
February 6, 2023
Prevision Policy Clips | CBER Deputy Celia Witten Will Lead Office Of Therapeutic Products
February 6, 2023
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
February 3, 2023
The Competing Legacies Of Aduhelm: FDA Feels Vindicated, But Expanding Role Of Accelerated Approval Depends On Heeding Calls For More “Transparency”
February 3, 2023
Prevision Policy Clips | Senate Finance Chair Wyden Urges CMS To Move Quickly On Medicare Rx Inflation Rebate Invoices
February 3, 2023
Prevision Policy Clips | House Hearing Suggests Bipartisan Interest In Banning “QALYs” In Federal Payment Policy
February 2, 2023
Accelerated Approval Changes In FDORA Play Well At NASEM Workshop; FDA Planning Multiple Guidances, Says “Authority” In Statute Will Help With Confirmatory Trials
February 1, 2023
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Guidance: Controlling Time Issues Is Key To Use In Studies For Regulatory Submission; Next Chapter In FDA’s RWE Draft Guidance Portfolio
February 1, 2023
FDA Office Of Regulatory Affairs Role Will Change As Part Of Broader Restructuring Focused On Food Safety; Details TBD
February 1, 2023
Prevision Policy Clips | FDA's Califf Faces First GOP Oversight Hearing
February 1, 2023
Advisory Committee Tracker: FDA Has Busy Start To 2023; Agenda Includes ALS Drug, Two RSV Vaccines, Another Unusual ODAC And Opioid Response Topics
January 31, 2023
CBER Gene Therapy "Super Office" Transition Includes New Leadership: OTAT Director Wilson Bryan To Step Down In Coming Weeks
January 31, 2023
Prevision Policy Clips | CBER Gene Therapy Review Office Will Have New Director; Wilson Bryan Is Retiring In March
January 31, 2023
Prevision Policy Clips | Biopharma Congress Is Two Weeks Away On Feb. 13: CBER Director Peter Marks
January 30, 2023
TGT’s MS Agent Briumvi May Have Some Convenience Advantage Over Genentech’s Ocrevus, ICER Panel Says, But Low Value Versus Generic Tecfidera
January 27, 2023
FDA Wants More COVID-19 Manufacturers At The Table: “Simplified” Vaccine Campaign Will Help, CBER’s Marks Says
January 27, 2023
Prevision Policy Clips | Second Naloxone OTC Application Heads To Advisory Committee March 20
January 27, 2023
FDA Punts To Congress On CBD Regulation: “New Pathway” Debate Will Reinforce Likelihood That Broader Drug Regulatory Topics Stay Out Of Political Spotlight
January 26, 2023
Cidara/Melinta’s Rezafungin On Track To Be First “Limited Use” Antifungal After Positive Committee Vote; Once-Weekly Dosing Viewed As Clear Clinical Advantage
January 26, 2023
Prevision Policy Clips | House Democrats Establish Committee Membership with New Jersey’s Frank Pallone
January 26, 2023
Prevision Policy Clips | Another AA Review By ODAC: Genentech Polivy Will Be Reviewed March 9 For First Line Indication
January 25, 2023
Prevision Policy Clips | Makena Gets Closer To Forced Withdrawal: Presiding Officer Celia Witten Agrees With CDER, Hearing Outcome
January 24, 2023
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