The FDA announced a major overhaul of its safety surveillance infrastructure by consolidating multiple adverse-event reporting systems into a single, unified Adverse Event Monitoring System. The move will fold vaccine and drug trackers—currently run across different centers and in partnership with the CDC—into one platform designed to streamline reporting and analysis. Agency materials indicate the new database will centralize submissions, enable cross-product signal detection, and standardize data capture across biologics, drugs and devices. Officials said the consolidation will improve the speed and clarity of safety signals while reducing fragmentation that has hampered cross-cutting reviews in the past. Manufacturers and pharmacovigilance teams will face migration tasks and updated reporting requirements. The change aims to give regulators a more integrated view of harms but raises transition and interoperability concerns for sponsors, health systems and third-party reporting services.