FDA Rolls Out AEMS Safety Dashboard, Saving $120M

The U.S. Food and Drug Administration (FDA) has launched the FDA Adverse Event Monitoring System (AEMS), a new centralized platform designed to analyze and publish adverse event reports across FDA-regulated products. The system, introduced on March 11, 2026, replaces several legacy safety reporting databases and reflects the agency’s effort to modernize post-market safety monitoring.

AEMS brings adverse event reports for drugs, biologics, vaccines, cosmetics, and animal food products into a single searchable dashboard. Previously, the FDA processed safety reports through multiple independent databases that the agency said were fragmented, difficult to navigate, and costly to maintain.

FDA Commissioner Marty Makary, M.D., M.P.H said the modernization effort addresses long-standing limitations in the agency’s safety reporting infrastructure.

“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access,” Makary said. “Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”

The agency receives roughly six million adverse event reports annually, previously distributed across seven separate databases. Operating these systems cost approximately $37 million per year, prompting the FDA to consolidate them into a single infrastructure.

According to the agency, the transition to AEMS is expected to generate about $120 million in cost savings over the next five years, while improving data accessibility and analytical capabilities.

Another key feature of the new platform is real-time publication of adverse event reports, replacing the earlier quarterly data releases. The FDA said this change will improve transparency and help researchers and regulators identify potential safety signals more quickly, while continuing to protect personally identifiable patient information.

Jeremy Walsh, the FDA’s Chief AI Officer, described the platform as the agency’s most significant technical transformation to date.

“Consolidating the FDA’s adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule,” Walsh said. “The team delivered the biggest technical transformation in agency history.”The rollout of AEMS will gradually replace several existing adverse event reporting databases. Systems transitioning immediately include FAERS, which collects reports related to drugs and biologics, VAERS, the vaccine safety reporting system co-managed with the CDC, and databases covering adverse events for animal drugs and animal food.

Additional systems are scheduled to migrate to AEMS by May 2026, including the MAUDE database for medical devices, the Human Foods Complaint System (HFCS), and the Center for Tobacco Products Adverse Event Reporting System (CTPAE).

Once the transition is complete, AEMS will serve as the FDA’s unified safety monitoring platform, allowing regulators, researchers, and the public to access adverse event data across all FDA-regulated product categories through a single system.

The FDA also introduced an AEMS Public Dashboard, an interactive web-based tool that allows the public to search and explore adverse event reports submitted by manufacturers, healthcare professionals, and consumers. The agency emphasized that while the dashboard expands access to safety data, the reports have important limitations.

The presence of an adverse event report does not confirm that a drug, biologic, or other regulated product caused the event, as reports may be incomplete, duplicated, or based solely on the reporter’s observations.

Reference

FDA Launches New Adverse Event Look-Up Tool, 11 March 2026, https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool

FDA Adverse Event Monitoring System (AEMS), 11 March 2026, https://www.fda.gov/safety/fda-adverse-event-monitoring-system-aems