by Admin | Mar 15, 2026 | AI & Digital PV
FDA’s January 2026 “Guiding Principles of Good AI Practice in Drug Development” lays out ten expectations for regulated AI, including human-centric design, a risk-based approach, clear context of use, multidisciplinary expertise, data governance, lifecycle management,...
by Admin | Mar 14, 2026 | AI & Digital PV
The FDA’s Guiding Principles of Good AI Practice in Drug Development, published on 14 January 2026, may not have been written specifically for pharmacovigilance, but they offer one of the clearest regulatory signals yet about how health authorities expect AI to be...
by Admin | Mar 14, 2026 | AI & Digital PV
The FDA’s Adverse Event Monitoring System (AEMS) is easy to describe as a modernization of public safety-data access, but that understates what the agency is building. FDA says AEMS will serve as a centralized platform not only for adverse event reporting but also for...
