“Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public,” said FDA Commissioner Marty Makary.

The new platform is called “FDA Adverse Event Monitoring System” (AEMS).
With this new system, adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal feed are now presented in a single, simplified dashboard. By the end of May 2026, the AEMS will contain real-time reports on adverse events for all products regulated by the FDA.

The FDA’s interest

In the past, the FDA processed approximately 6 million adverse event reports per year from a disparate set of seven databases, which were costly and had a poor user interface, making searches difficult, according to the Agency itself.
These platforms cost approximately $37 million per year to operate. With the AEMS, the Agency expects to save approximately $120 million over the next five years.

The FDA also expects that the new search system will significantly reduce Freedom of Information Act (FOIA) requests for unpublished adverse event reports, as the EMA will publish reports in real time rather than quarterly.

The limits of the system