STAT+: FDA launches unified system for adverse event reports

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Source: STAT News

Original: https://www.statnews.com/2026/03/12/biotech-news-fda-system-adverse-event-report...

Published: Thu, 12 Mar 2026 14:16:53 +0000

The US FDA has launched a new digital platform called the FDA Adverse Event Monitoring System (AEMS), which will merge multiple adverse event reporting databases into one comprehensive system.[1][3] The system is supposed to modernize the safety monitoring of products such as drugs, vaccines, cosmetics, medical devices, food, dietary supplements and tobacco products.[1][3][4] Previously, the FDA processed approximately 6 million reports per year in seven separate databases, costing $37 million annually.[1][3] With AEMS, the agency expects to save $120 million over five years and publish real-time reports instead of quarterly updates.[1][3] The platform will provide a unified dashboard for scientists, researchers and the public, while maintaining patient privacy.[1][3] By May 2026, data from legacy systems such as FAERS, VAERS and AERS will be transferred to the system.[1][3] AEMS uses AI tools to redact and analyze data, thereby improving the identification of security signals.[4][5] In addition to adverse events, it will also serve on consumer complaints and whistleblower reports.[4][5]