FDA Launches Adverse Event Monitoring System (AEMS)

The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports.

This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products. “The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access.

These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re fixing the problem through a major modernization initiative.

Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.” With the new system, adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. In the months ahead, all remaining product centers will begin processing adverse event reports in AEMS.