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Orphan Drug Price Negotiation Fixes Remain A Partisan Issue During House Hearing; Democrats Also Raise Issues With Rare Disease PRV Reauthorization
March 1, 2024
RWE Efforts Need Better Data Standards And Quality – No Matter The Regulatory Intent, OCE’s Kluetz Says; Case Studies Show Even “Failed” Attempts Have Benefits
March 1, 2024
Prevision Policy Clips | Medicare Part D Co-Pay “Smoothing” Option Will Be Offered To Any Beneficiary With Co-Pay Of $600
March 1, 2024
“Point/Counterpoint” Joint Advisory Committee Documents Will Remain The Norm For ODAC, But Not For Other CDER Committees
February 29, 2024
Advisory Committee Tracker: Agenda Still Sparse As FDA Prepares For In-Person Meetings To Return This Fall
February 29, 2024
Prevision Policy Clips | FDA Informed Consent “Key Information” Draft Guidance Includes Template
February 29, 2024
“We’re Coming Back”: Most Advisory Committees Will Be In-Person This Fall; Changes In Recruitment Are Underway – But The Votes Will Stay
February 28, 2024
FDA’s Gene/Cell Therapy Office Ramp Up Will Take 2-3 Years, CBER’s Marks Predicts; Will 2027 Be A Milestone Year For Rare Disease Organization At FDA?
February 28, 2024
Prevision Policy Clips | Manufacturing User Fees Floated By Woodcock To Better Fund Inspections
February 28, 2024
Pepaxto Withdrawal Indicates FDORA Has Improved The Process For Pulling Accelerated Approval – But Not Solved All FDA’s Problems
February 27, 2024
Prevision Policy Clips | CMMI Will Issue Further Details, Requests For Applications For Cell/Gene Therapy Access Model “Very Soon”
February 27, 2024
Prevision Policy Clips | Office Of Therapeutic Products “75%-80%” Staffed, CBER Director Peter Marks Says
February 26, 2024
Prevision Policy Clips | CDER Approved 90 First Generics In 2023: Office Of Generic Drugs Annual Report
February 23, 2024
Rare Disease Regulatory Consistency: CBER’s Marks Predicts Greater Harmony In FDA Advice In Near Future During MPS Meeting; Biologics as Lead Center?
February 22, 2024
ICER Review Of Novartis And AstraZeneca PNH Therapies: Patient Adherence Will Be Critical Issue For Uptake Of Novel Oral Treatments, Panel Says
February 22, 2024
Prevision Policy Clips | Biopharma Congress Is Sold Out
February 22, 2024
Gene Therapy International Cooperation: FDA Hopes Simultaneous Reviews By Key Regulatory Bodies Will Make Some Rare Disease Markets More Viable
February 21, 2024
Diversity Action Plan Guidance Delayed As FDA Works To “Provide More Information”; OTP’s Fashoyin-Aje Says FDA Interprets Diversity “Very Broadly”
February 21, 2024
Prevision Policy Clips | FDA Updates COVID Therapeutics Development Guidance: New Version
February 21, 2024
Prevision Policy Clips | Iovance Amtagvi (Lifileucel) Melanoma Approval Is “First Tumor-Derived T-Cell Immunotherapy”
February 20, 2024
Implementing “Project Optimus”: Oncology Dose Optimization Can Learn From Other Areas – But Cancer Will Still Be Different; AACR Workshop Drills Down On Approaches
February 16, 2024
Prevision Policy Clips | Part D Co-Pay “Smoothing”: CMS Releases Second Implementation Guidance, Focusing On Pharmacy Outreach
February 16, 2024
CBER Readying For Next COVID Vaccine Strain Selection, Director Marks Says During House Hearing On Vaccine Safety Systems
February 15, 2024
Wholesaler/GPO Role In Drug Shortages Is New Focus For HHS/FTC Competition Initiative; RFI Asks About Impact Of Consolidation, Contracting On Supply Chain
February 15, 2024
Prevision Policy Clips | The New Accelerated Approval Withdrawal Process: “Stay Tuned…In Coming Weeks,” FDA’s Marks
February 15, 2024
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