Prevision Policy Clips | Senate Aging Committee Hearing Will Look at FDA Rare Disease Review Process

CMS Final Part B Physician Rule Drops Plan To Redefine “Bona Fide Service Fees” For Now; Manufacturers Will Still Be Expected To Document “Fair Market Value” Calculation

CDER Director Search: HHS Appears To Land On OND’s Thanh Hai After OCE’s Pazdur Turns Down The Job

Prevision Policy Clips | Medicare Obesity Drug Coverage Will Be Tied To GLP-1 Pricing Deal With Novo And Lilly

“Seamless” Trial Designs In Rare Cancers Remain Underutilized But Are Effective With Advanced Planning; “Reacting In Real Time” Does Not Work

Medicare Pricing Support For Generic Injectables Could Offer Point Of Departure To Rebuild Resiliency; NASEM Workshop Hears Suggestions For Where To Start

Prevision Policy Clips | CDER Leadership Uncertain Amid Tidmarsh Drama

CDER’s Tidmarsh Departs Abruptly, Casting Shadow Over CNPV Roll-Out; Opening For CBER/CDER Consolidation Under Prasad?

Prevision Policy Clips | CDER’s Tidmarsh Forced Out As FDA Leadership Drama Continues

FDA Deadline Tracker: Biohaven Troriluzole Will Test FDA’s Current Posture On Rare Disease Flexibility; Five Other NMEs Could Make For Busy November

Prevision Policy Clips | 340B Rebate Model Will Include 9 Of The 10 Eligible Drugs Effective January 1

PDUFA VIII Process Likely To Focus On Competition From China; Maintaining US Biotech Leadership Is Key Bipartisan Theme As BIO Unveils FDA Reform Wishlist

Prevision Policy Clips | HHS Casts Biosimilars Guidance As “Major Action” To Lower Drug Costs, No IRA Prices Yet

FDA Draft Guidance Proposes Dropping Comparative Efficacy Studies For Biosimilars In Many Cases; “Significant Experience” In Biosimilar Evaluation Allows Greater Streamlining

Prevision Policy Clips | HHS To Unveil “Major Actions To Lower Drug Costs” Today

CDER Director Tidmarsh Suggests Staff Morale Is Strengthening; Efficiency Changes Will Help Industry And Reviewers, He Says

Advisory Committee Tracker (Shutdown Edition): Digital Health, Pediatric ACs Still Set To Meet In November, But No Product Reviews Scheduled

Prevision Policy Clips | Office of New Drugs Director Is Mary Thanh Hai

Prevision Policy Clips | FDA Brings Back CDER Executive Operations Team

FDA Underscores Importance Of Identifying Meaningful Aspects Of Health For COA Development In Final Guidance

FDA Final Expanded Access Q&A Guidance Has Minimal Changes From Draft; New Appendix Summarizes EA Categories, Timelines, And Requirements

Prevision Policy Clips | GSK’s Blenrep Returns To US Market For Third-Line Multiple Myeloma Use

340B Reform: Political Cross-Currents On Display During Senate Hearing; Cassidy Will Defer To Bipartisan “Gang Of Six” On Legislation

FDA’s CNPV Program: Codifying Vouchers Into Law Would Increase Transparency, Former Officials Say; Can Review Teams Handle The Extra Load?

Prevision Policy Clips | “America First” User Fees? Commissioner Makary Proposes Higher Fees For Products Studied Outside US