Washington, D.C.(WDNews) — The U.S. Food and Drug Administration has launched a new digital platform designed to improve how the agency tracks and analyzes reports of adverse events linked to regulated products.
The new system, called the FDA Adverse Event Monitoring System, or AEMS, will combine multiple reporting databases into one streamlined platform. Officials say the move is intended to modernize the agency’s safety monitoring and improve public transparency.
FDA Commissioner Marty Makary said the previous reporting systems were outdated and fragmented, making critical safety data harder to access. He said the new platform will give agency scientists, researchers and the public a single dashboard to view reports tied to drugs, vaccines, cosmetics and other regulated products.
The FDA currently receives about 6 million adverse event reports each year. Those reports were previously processed across seven separate databases that cost about $37 million annually to operate. With AEMS, the agency expects to save about $120 million over the next five years.
Officials say the system will also publish reports in real time rather than quarterly, which could reduce the number of Freedom of Information Act requests for adverse event data.
According to the FDA, the platform will eventually include data from several legacy systems, including FAERS, VAERS and AERS. Additional systems that track reports for medical devices, foods, dietary supplements and tobacco products are expected to transition into AEMS by May 2026.
The agency says the new system will continue protecting patient and consumer privacy while improving the ability to identify potential safety signals tied to FDA-regulated products.
Chief AI Officer Jeremy Walsh called the transition the largest technical overhaul in the agency’s history, saying the unified platform will improve how the FDA monitors potential risks after products reach the market.
