News Tag ‘RegulatoryAffairs’

FDA maintains a publicly available, regularly updated list of potential safety signals identified from its FAERS spontaneous reporting database, but inclusion on the list does…

The U.S. Food and Drug Administration (FDA) has announced a significant update to its approach to real-world evidence (RWE), removing a major limitation that has…

The European Medicines Agency (EMA) has published Revision 3 of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorization, introducing updated…

The European Medicines Agency (EMA) has updated its post-authorization guidance in November 2025, clarifying variation classifications for marketing authorization holders. These revisions address administrative, quality,…

The U.S. Food and Drug Administration (FDA) has qualified the first artificial intelligence tool for drug development, specifically AIM-NASH, designed to aid pathologists in evaluating…