FDA and EMA Release Guiding Principles of Good AI Practice in Drug DevelopmentJanuary 14, 2026January 14, 2026
This Week at FDA: FDA Eases Digital Health Oversight, MDUFA Negotiation Update, and MoreJanuary 9, 2026January 14, 2026
This Week at FDA: FDA Staff Raise Alarm Over CNVP, No COVID-19 Vaccine Boxed Warning, and MoreDecember 19, 2025December 23, 2025
FDA Loosens Restrictions on Using Patient-Level RWD in Medical Device SubmissionsDecember 18, 2025December 23, 2025
This Week at FDA: Anti-abortion Groups Want Makary Fired, FDA Investigating RSV VaccinesDecember 12, 2025December 13, 2025
FDA Qualifies First AI Drug Development Tool, Will Be Used in ‘MASH’ Clinical TrialsDecember 9, 2025December 13, 2025
Appointment of Controversial Official Rocking FDA Like “an atom bomb”December 8, 2025December 13, 2025
This Week at FDA: Makary Teases Plan for Single-Trial Drug Approvals, Høeg Named Acting CDER Chief, and MoreDecember 5, 2025December 6, 2025
