The Food and Drug Administration (FDA) just rolled out a brand-new AI-powered system designed to track adverse effects from drugs, vaccines, cosmetics, and other consumer products nationwide. This new platform, called the FDA Adverse Event Monitoring System (AEMS), went live on Tuesday, marking a massive shift in how the agency handles product safety.
According to FDA Commissioner Marty Makary, the old, fragmented systems created “large blind spots” in post-market surveillance. He didn’t pull any punches, stating that these systems “wasted taxpayer dollars” and left critical gaps in understanding how products perform once they hit the wider market. The AEMS is here to fix that, offering a single, intuitive platform that will give both the FDA and interested researchers access to key data and insights in real time.
