Federal News
FDA Launches Adverse Event Monitoring System
March 12, 2026
The U.S. Food and Drug Administration (FDA) has launched the FDA Adverse Event Monitoring System (AEMS), a unified, real-time platform consolidating multiple legacy adverse event reporting systems into a single dashboard. This modernization effort aims to enhance transparency and improve the efficiency of postmarket surveillance activities. The initiative is projected to save the agency approximately $120 million over five years, reflecting significant cost efficiencies and technological advancement in FDA's data management and reporting capabilities.
- The consolidation into a single platform streamlines adverse event data collection and dissemination, improving accessibility for agency scientists, researchers, and the public.
- Procurement professionals should note the scale and technical complexity of this modernization, which may signal future opportunities for vendors specializing in real-time data systems, dashboard development, and health IT modernization.
- The cost savings highlight the FDA's focus on efficient technology investments, suggesting a continued emphasis on digital transformation projects within HHS agencies.
- Organizations supporting postmarket surveillance and regulatory compliance can leverage this platform's capabilities to enhance their service offerings and align with FDA's evolving data infrastructure.
Weβre 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.
— Marty Makary, M.D., M.P.H., FDA Commissioner
Consolidating the FDAβs adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule. The team executed with perfection and delivered the biggest technical transformation in agency history. This is the new FDA.
— Jeremy Walsh, Chief AI Officer
Agencies
U.S. Food and Drug Administration, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
Locations
Sources
- FDA Launches New Adverse Event Look-Up Tool | FDA · FDA · Mar 12