CMS Sickle Cell Gene Therapy Access Model Creates 18-Month Period For Bluebird, Vertex And State Medicaid Programs To Work Out Rebate Agreements

Prevision Policy Clips | Bespoke Gene Therapy Development “Playbook” Released By FNIH

FDA’s Overseas Inspector Vacancies Need Innovative Solutions, House Leadership Says; Unannounced Visits In China Still Delayed

CDER Plans AI In Drug Development Guidance For 2024; New RWE Guidance Added To Regulatory Agenda

Prevision Policy Clips | Valneva Sells Priority Review Voucher For $103 Million

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

FDA Oncology Diagnostics Pilot Is An “Interim Step” To Fill VALID Void, But “Stuck In Neutral” As Agency Waits To Sign Up Sponsors

Prevision Policy Clips | Manufacturer Quantity Reports: FDA Finalizes Guidance For Submissions Of Production Amounts, But Delays Effective Date

Advisory Committee Tracker: CAR-T Reviews Highlight Upcoming Agenda As Lull Comes To An End

Prevision Policy Clips | FDA Sets March 15 Date For Abecma, Carvykti sBLA AdComm: “General Discussion Focused On The Overall Survival Data”

Awkward Allies On Medicare Price Negotiation? 340B Providers Could Face Significant Loss Once IRA Price Cuts Are Implemented

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

Prevision Policy Clips | Advisory Committee Revamp Still Under Internal Debate, But FDA Already Getting Better Experts

Prevision Policy Clips | Biogen To Discontinue Aduhelm: Landmark And Contentious Approval Ends With A Whimper

Remote Regulatory Assessments: FDA Updates Draft Guidance To Incorporate FDORA Authorities For “Remote Inspections”; Friendlier Tone Encouraging Firms To Participate When RRAs Are “Voluntary”

Prevision Policy Clips | CBER Plans Cell And Gene Therapy FAQ Draft Guidance For 2024 Publication, Quick Turnaround Anticipated For Potency Assurance Guidance

FDA Revises Race And Ethnicity Data Collection Guidance But “Demographic Rule” Review May Lead To Future Changes; Diversity Action Plans Fall Outside Of Scope

Prevision Policy Clips | ODAC To Review Geron’s Imetelstat For MDS On March 14

Prevision Policy Clips | Biopharma Congress Is Only One Month Away: CBER’s Peter Marks and Celia Witten, OCE’s Richard Pazdur and Janet Woodcock

Pre-Term Birth Drug Development After Makena: New Endpoints Await Better Understanding Of Etiology; Modeling Approaches May Help

Senate Finance Drug Shortages White Paper Focuses On Generic Injectable Payment In Medicare; Outpatient Drug Ideas – Including Medicaid Rebate Changes – Appear Farther Away

Prevision Policy Clips | FDA Updates Remote Regulatory Assessment Q&A Guidance: FDORA Provisions

AI Neuroscience Tool For Depression Accepted By FDA Into ISTAND Program; Milestone In Rapidly Advancing Field – But Still Long Process Ahead

Prevision Policy Clips | Another CAR-T sBLA Advisory Committee: J&J/Legend’s Carvykti Will Go To ODAC For Label Expansion

MIE Time? FDA Urging Participation in Generic Drugs Model-Integrated Evidence Meeting Pilot; Says Modeling Will Be “Essential” For Future Of Generic Development