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...
by Admin | Mar 14, 2026 | Regulatory Updates
A new Fierce Pharma report says the biopharma industry is heading into a more difficult 2026 as major companies confront a mix of patent expirations, slowing growth, and uneven commercial outlooks. The article, published March 13, 2026, says that among the world’s 25...
by Admin | Mar 14, 2026 | Inspections & Compliance
MHRA has reviewed how risk information is communicated for gabapentinoids, benzodiazepines, and z-drugs and concluded that warnings on these medicines need to be strengthened. The agency said it was necessary to improve the warnings regarding addiction, dependence,...
by Admin | Mar 14, 2026 | Explainers
The FDA’s new Adverse Event Monitoring System (AEMS) includes a page dedicated to new safety information or potential signals of serious risks identified through postmarketing surveillance. FDA says AEMS is being implemented to consolidate multiple reporting systems...
