Prevision Policy Clips | Pfizer Will Present On Three Vaccine Candidates During February ACIP Meeting

“The Will” Vs. “The Wait”: CBER’s Marks, OTAT’s Bryan Give Differing Views Of Accelerated Approval For Gene Therapies

Emergent’s Narcan Nasal Spray Unanimously Supported For OTC Use; Set To Be First Nonprescription Opioid Reversal Agent – And First-Of-Its Kind FDA-Initiated Public Health Switch

Prevision Policy Clips | FDA Office Of Oncologic Diseases Deputy Director Slot Vacant After Julia Beaver Departs

FDA Gene Therapy Reorg: Industry Should Expect “A Year Or Two” For Staffing To Catch Up With Demand; Policy Plans Include “Platform,” Efforts Inspired By “Warp Speed,” RTOR And Orbis

FDA’s Califf Calls For Return To Large, Simple Trials Without “Useless Stuff” That Slows Development; Praises OCE’s “Project Pragmatica”

CMMI Drug Pricing Models: $2 Generics Ready To Go; Centralized Gene Therapy Contracts May Support SCD Launches; Can CMS Help Accelerated Approval?

Prevision Policy Clips | Moderna To Testify At Senate HELP Committee On COVID Vaccine Pricing Plans

FDA Advisory Committees Moving To In-Person Meetings: Califf Envisions Earlier, Big-Picture Topics For Discussion, Less “Gladiator”-Type Approval Votes

Prevision Policy Clips | Drug Pricing Demos Announced By HHS—But Implementation Timeline And Details Are Still TBD

CMS Considering New Approaches For Gene Therapy In Medicaid, But Not ASP Or “Protected Class” Changes; COO Blum Calls For Data On IRA Impact On Innovation

Prevision Policy Clips | CBER Listening Session On Cell/Gene Therapy Data Collection From RWE/Registries

Prevision Policy Clips | CBER Working On Warp Speed For Rare Diseases, Director Peter Marks

Project Orbis Update: 71 Orbis Approvals and Counting Since Program Began in 2019

GSK Jemperli Accelerated Approval In Rectal Cancer Is Possible With Tweaks To Proposed Plan, FDA Committee Says; Model For AA Plans?

USPTO/FDA Coordination On Patents: First Practical, Politically Palatable Lesson May Be For PTO To Adopt FDA Processes For Soliciting Patient Perspective

Medicare Inflation Rebate Implementation Plan Unveiled: Manufacturers Would Have 10 Days To Check Invoices For Errors Under Proposed Policy; CMS Expects First Invoices In 2025

Prevision Policy Clips | FDA Commissioner Robert Califf To Keynote Biopharma Congress On February 13; FDORA, Impacts Of The IRA

Pharma Patent/Competition Bills Return In Senate; Bipartisan Talks Continue On Scope Of FTC Authorities

FDA/Sponsor Communication To Be Subject Of House E&C Hearings; Advisory Committees, Inspections Among Other Questions For Califf During COVID Hearing

Prevision Policy Clips | FDA COVID “Direct-To-Final” Guidance Clean-Up: Agency Withdraws Propofol Re-Packaging Policy

Accelerated Approval For Gene Therapies: OTAT Town Hall Suggests Pathway Viable In Slowly Progressive Disease With Clear Natural History

“Project Pause”? FDA Cancer Center Launches Fewer New Projects In 2022 To Allow Time To Advance Existing Work

Prevision Policy Clips | President Biden Takes IRA Victory Lap During State Of The Union

GSK’s Jemperli ODAC May Be Public Test Case For Accelerated Approval Development Meetings; Committee To Discuss Novel Endpoints At IND Stage