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Prevision Policy Clips | CBER OTP Head: Blood Office Director Nicole Verdun
August 3, 2023
Essential Medicine “Buffer Stock” Incentive For Hospitals Floated By CMS As Potential Tool To Prevent Shortages
August 3, 2023
FDA Advisory Committee Revamp Will Focus On Streamlined Logistics For Members, Cross-Cutting Regulatory Topics And Hybrid Meetings
August 2, 2023
NTAP Class Of 2024 Includes 11 New Drugs; CMS Changes Timelines For Future Applicants For Hospital Add-On Payments
August 2, 2023
Prevision Policy Clips | CMS Grants New Technology Add-on Payments For 11 New Drugs, Changes Timelines For Future NTAP Requests
August 2, 2023
Advisory Committee Tracker: Alnylam Onpattro sNDA, BrainStorm Filed-Over-Protest BLA Offer Contrasting Rare Disease Reviews For September
August 1, 2023
Prevision Policy Clips | Part D Average Premium Set To Decline In 2024, Even As Benefit Becomes More Generous
August 1, 2023
Prevision Policy Clips | House GOP Drug Shortage Bill Leans In To Incentives For Manufacturers; One-Month Exclusivity Extension
July 31, 2023
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
July 28, 2023
Prevision Policy Clips | Lovo-Cel v. Exa-Cel Sickle Cell Gene Therapies: ICER Advisory Group Finds No Difference
July 28, 2023
PBM Reform Legislation Picking Up Steam: Senate Finance “De-Linking” Bill Moves To Floor; Comprehensive In Scope But Modest Impact – For Now
July 27, 2023
Prevision Policy Clips | House Health Care Transparency Bill Reported Out Of Ways & Means Committee, With Part D Provision
July 27, 2023
Prevision Policy Clips | FDA Confirms Sept. 27 Advisory Committee Date For BrainStorm Filed-Over-Protest ALS Cell Therapy NurOwn
July 26, 2023
Prevision Policy Clips | Senate Finance PBM Reforms Would Save Approximately $1.7 Billion
July 25, 2023
PAHPA Reauth Update: Proposals Move From House, Senate Committees; Senate Adds Drug Shortage Measures, VALID Likely To Wait Until Fall
July 24, 2023
Prevision Policy Clips | BioMarin Roctavian Severe Hemophilia A Gene Therapy FDA Approval Summary
July 24, 2023
Clinical Trial Diversity Plans: FDA Will Publish First Analysis “Shortly”; OCE Notes That Current Guidance Will Be Supplanted By FDORA “Diversity Action Plans”
July 21, 2023
Prevision Policy Clips | Senate HELP Committee Advances PAHPA Legislation
July 21, 2023
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”
July 20, 2023
Prevision Policy Clips | VALID Act To Be Reconsidered By Congress In Fall
July 20, 2023
Prevision Policy Clips | Senate PAHPA Reauthorization Draft Adds Provisions Tweaking FDA Supply Notification Requirements
July 19, 2023
FDA Post-COVID Inspection Plans For China And India Probed By House GOP; Key Vulnerability For Agency – With Cancer Drug Shortages As Headline Focus
July 18, 2023
Prevision Policy Clips | CMS Removes Restriction On Beta Amyloid PET Scans
July 18, 2023
FDA Pressing For Standardization In ctDNA Trials; FoCR Webinar Highlights Continued Engagement And Slow Path Forward
July 17, 2023
Prevision Policy Clips | AZ/Sanofi Nirsevimab Coverage Recommendation Will Be Voted On By ACIP
July 17, 2023
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