FDA Final Expanded Access Q&A Guidance Has Minimal Changes From Draft; New Appendix Summarizes EA Categories, Timelines, And Requirements

Prevision Policy Clips | GSK’s Blenrep Returns To US Market For Third-Line Multiple Myeloma Use

340B Reform: Political Cross-Currents On Display During Senate Hearing; Cassidy Will Defer To Bipartisan “Gang Of Six” On Legislation

FDA’s CNPV Program: Codifying Vouchers Into Law Would Increase Transparency, Former Officials Say; Can Review Teams Handle The Extra Load?

Prevision Policy Clips | “America First” User Fees? Commissioner Makary Proposes Higher Fees For Products Studied Outside US

Common Inspection Findings In Cell/Gene Therapy Facilities: FDA Emphasizes Importance Of Sterility, Quality Assurance Oversight

Prevision Policy Clips | Pediatric PRV Renewal Could Move Through House Via Suspension Of Rules

Beyond The QALY: ICER/Canada/U.K. Collaboration Outlines Approach For Considering Other Benefits Like Patient Preference; “Opportunity Cost” Must Always Be Weighed, Report Suggests

The Future Role Of The FDA Reviewer With AI: “To Be The Responsible Person”; ELSA LLM Gets High Marks From Agency Staffers

Sanofi’s Tzield sBLA, Disc’s Bitopertin Will Be First Tests Of CNPV Pathway, But Process May Look Different For Each Candidate; Sponsor Readiness Is A Factor, FDA’s Makary Says

Prevision Policy Clips | FDA’s Prasad Raves About Regeneron DB-OTO Gene Therapy

Prevision Policy Clips | FDA Hiring Data Confirms Loss Of Drug Center Staffing: CDER Down 18%, CBER Down 14%

Commissioner Vouchers Awarded To Nine Drugs With More Coming; Divisions Are Picking The Candidates, FDA Deputy CMO Mundkur Appears To Be Leading Reviews

Prevision Policy Clips | FDA Announces Inaugural Recipients Of Commissioner’s National Priority Vouchers

Osteosarcoma Drug Development Challenges: FDA Oncology Team Eager To Work Through Issues – But Reluctant To Use Regulatory Fiat To Order Trials

Prevision Policy Clips | ELSA AI Model Receives Praise, Being Used In Five Primary Areas

Prevision Policy Clips | Krystal Biotech’s HSV-1 Viral Vector Receives FDA Platform Designation

“Hybrid” Inspections Final Guidance: Sponsors That Decline To Accept Remote FDA Participation In Pre-Approval Inspections May “Prolong” Process

Prevision Policy Clips | AstraZeneca Pricing Deal Follows Pfizer Template

Prasad’s CBER Takes Shape: Promotions Include Two Deputies To Share Number-Two Spot; Goldberg Is Now CMO, Steele To Oversee Pandemic Preparedness

Federal Procurement Policy May Be Tool To Increase Domestic Manufacturing of Generic Drugs, Senate Aging Committee Leadership Suggests; Country-of-Origin Labeling Also Has Bipartisan Support

Prevision Policy Clips | FDA Posts Five More CRLs, With Another Coming Soon

Oncology PROs Should Capture Specific Measurements Of Toxicity; Use Of Global Quality-Of-Life Assessments To Claim Tolerability Is “Not Acceptable,” FDA Says

Prevision Policy Clips | CMMI “Exploring” GLP-1s For Weight Loss Model

Malaria Trials May Use Non-FDA Approved Comparators, Draft Guidance Says, But FDA Approved Controls Preferred; Fourth Anti-Infectives Guidance Of Trump Era