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Prevision Policy Clips | Data Monitoring Committees Guidance: FDA Maintains Recommendations For A Charter Detailing Obligations, Responsibilities, And Procedures
February 12, 2024
Prevision Policy Clips | Diversity Action Plans Guidance: FDA “Actively Working” On Draft
February 9, 2024
Senate “Show Trial” On Drug Pricing Allows CEOs To Pitch Co-Pay And Contracting Reform Agenda; Medicare Negotiation Hangs Over Event – But Details Not Discussed
February 8, 2024
The War On Drug Shortages? Onshoring Push Would Start With Battlefield Medicines Under House Bill Discussed During Ways & Means Hearing; “Buffer Stocks” Also Have Support
February 8, 2024
Building Quality By Design In Clinical Trials Starts With Predicting What Can Go Wrong, FDA’s Stein Says; Natural History, Diversity Key Factors In Rare Diseases
February 8, 2024
Prevision Policy Clips | FDA’s VRBPAC To Review Flu Strains For Vaccines On March 5
February 8, 2024
Bespoke Gene Therapy Consortium “Playbook” For AAV Gene Therapy Development Published; “Platform-Approach” Could Be Model For New Pathway
February 7, 2024
CMS Sickle Cell Gene Therapy Access Model Creates 18-Month Period For Bluebird, Vertex And State Medicaid Programs To Work Out Rebate Agreements
February 7, 2024
Prevision Policy Clips | Bespoke Gene Therapy Development “Playbook” Released By FNIH
February 7, 2024
FDA’s Overseas Inspector Vacancies Need Innovative Solutions, House Leadership Says; Unannounced Visits In China Still Delayed
February 7, 2024
CDER Plans AI In Drug Development Guidance For 2024; New RWE Guidance Added To Regulatory Agenda
February 6, 2024
Prevision Policy Clips | Valneva Sells Priority Review Voucher For $103 Million
February 6, 2024
Manufacturer Quantity Report Guidance Finalized: 2023 Data Due In August, FDA Says; Older Reports Should Be Submitted “As Soon As Possible” – And All Will Be Kept Confidential
February 5, 2024
FDA Oncology Diagnostics Pilot Is An “Interim Step” To Fill VALID Void, But “Stuck In Neutral” As Agency Waits To Sign Up Sponsors
February 5, 2024
Prevision Policy Clips | Manufacturer Quantity Reports: FDA Finalizes Guidance For Submissions Of Production Amounts, But Delays Effective Date
February 5, 2024
Advisory Committee Tracker: CAR-T Reviews Highlight Upcoming Agenda As Lull Comes To An End
February 2, 2024
Prevision Policy Clips | FDA Sets March 15 Date For Abecma, Carvykti sBLA AdComm: “General Discussion Focused On The Overall Survival Data”
February 2, 2024
Awkward Allies On Medicare Price Negotiation? 340B Providers Could Face Significant Loss Once IRA Price Cuts Are Implemented
February 1, 2024
340B At A “Critical Inflection Point,” HRSA’s Pedley Says – But Congress, HRSA Unlikely To Clarify Scope Of Eligibility For Discounts Or Resolve Contract Pharmacy Rules Any Time Soon
February 1, 2024
Prevision Policy Clips | Advisory Committee Revamp Still Under Internal Debate, But FDA Already Getting Better Experts
February 1, 2024
Prevision Policy Clips | Biogen To Discontinue Aduhelm: Landmark And Contentious Approval Ends With A Whimper
January 31, 2024
Remote Regulatory Assessments: FDA Updates Draft Guidance To Incorporate FDORA Authorities For “Remote Inspections”; Friendlier Tone Encouraging Firms To Participate When RRAs Are “Voluntary”
January 30, 2024
Prevision Policy Clips | CBER Plans Cell And Gene Therapy FAQ Draft Guidance For 2024 Publication, Quick Turnaround Anticipated For Potency Assurance Guidance
January 30, 2024
FDA Revises Race And Ethnicity Data Collection Guidance But “Demographic Rule” Review May Lead To Future Changes; Diversity Action Plans Fall Outside Of Scope
January 29, 2024
Prevision Policy Clips | ODAC To Review Geron’s Imetelstat For MDS On March 14
January 29, 2024
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