The US Food and Drug Administration (FDA) has launched a new combined adverse event database. The Adverse Event Monitoring System (AEMS) will consolidate several systems that currently exist for reporting different types of adverse events.
The FDA states that: ‘By the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products, consistent with meeting agency obligations not to release individually identifiable patient or consumer information’.
The AEMS will function not only as the system for adverse event reporting, but also as a unified platform for managing consumer complaints, regulatory misconduct reports and whistleblower submissions across all FDA centres. By consolidating these activities, the FDA anticipates improved cross-category safety surveillance and more timely, well-informed regulatory decision-making.
A press release states that the system ‘represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products’.
The dashboard can be accessed here.
