Office Of Therapeutic Products Director Verdun Is A CBER Veteran; Internal Candidate Chosen For High-Profile Post Overseeing Gene/Cell Therapy Reviews

Prevision Policy Clips | CBER OTP Head: Blood Office Director Nicole Verdun

Essential Medicine “Buffer Stock” Incentive For Hospitals Floated By CMS As Potential Tool To Prevent Shortages

FDA Advisory Committee Revamp Will Focus On Streamlined Logistics For Members, Cross-Cutting Regulatory Topics And Hybrid Meetings

NTAP Class Of 2024 Includes 11 New Drugs; CMS Changes Timelines For Future Applicants For Hospital Add-On Payments

Prevision Policy Clips | CMS Grants New Technology Add-on Payments For 11 New Drugs, Changes Timelines For Future NTAP Requests

Advisory Committee Tracker: Alnylam Onpattro sNDA, BrainStorm Filed-Over-Protest BLA Offer Contrasting Rare Disease Reviews For September

Prevision Policy Clips | Part D Average Premium Set To Decline In 2024, Even As Benefit Becomes More Generous

Prevision Policy Clips | House GOP Drug Shortage Bill Leans In To Incentives For Manufacturers; One-Month Exclusivity Extension

Exclusivity Extension For Shelf-Life Studies Is Among Carrots For Industry In House GOP Shortage Bill; Inflation Rebate Relief Also Proposed – As Is Potential Route To Part B Reimbursement Reform

Prevision Policy Clips | Lovo-Cel v. Exa-Cel Sickle Cell Gene Therapies: ICER Advisory Group Finds No Difference

PBM Reform Legislation Picking Up Steam: Senate Finance “De-Linking” Bill Moves To Floor; Comprehensive In Scope But Modest Impact – For Now

Prevision Policy Clips | House Health Care Transparency Bill Reported Out Of Ways & Means Committee, With Part D Provision

Prevision Policy Clips | FDA Confirms Sept. 27 Advisory Committee Date For BrainStorm Filed-Over-Protest ALS Cell Therapy NurOwn

Prevision Policy Clips | Senate Finance PBM Reforms Would Save Approximately $1.7 Billion

PAHPA Reauth Update: Proposals Move From House, Senate Committees; Senate Adds Drug Shortage Measures, VALID Likely To Wait Until Fall

Prevision Policy Clips | BioMarin Roctavian Severe Hemophilia A Gene Therapy FDA Approval Summary

Clinical Trial Diversity Plans: FDA Will Publish First Analysis “Shortly”; OCE Notes That Current Guidance Will Be Supplanted By FDORA “Diversity Action Plans”

Prevision Policy Clips | Senate HELP Committee Advances PAHPA Legislation

The Future Of OS In Oncology: FDA Workshop Focuses On Challenges With Survival Endpoints As Cancer Care Improves; Accelerated Approval Is One Tool FDA May Use When OS Is “Uncertain”

Prevision Policy Clips | VALID Act To Be Reconsidered By Congress In Fall

Prevision Policy Clips | Senate PAHPA Reauthorization Draft Adds Provisions Tweaking FDA Supply Notification Requirements

FDA Post-COVID Inspection Plans For China And India Probed By House GOP; Key Vulnerability For Agency – With Cancer Drug Shortages As Headline Focus

Prevision Policy Clips | CMS Proposes To Remove Restriction On Beta Amyloid PET Scans

FDA Pressing For Standardization In ctDNA Trials; FoCR Webinar Highlights Continued Engagement And Slow Path Forward