The U.S. Food and Drug Administration (FDA) has launched a single platform for analyzing adverse event reports across all product categories the agency regulates.
With the new FDA Adverse Event Monitoring System (AEMS), the FDA Adverse Event Reporting System (FAERS), which contained reports for drugs, biologics, cosmetic products, and color additives, will be among the first to be replaced. The Manufacturer and User Facility Device Experience (MAUDE) database for medical devices is scheduled for replacement in May.
AEMS consolidates reporting that was previously spread across seven databases, which collectively cost the agency approximately $37 million per year to operate, according to the agency. The FDA expects to save approximately $120 million over the next five years with the new system.
"Transparency around adverse event reports submitted by patients, consumers, clinicians, and manufacturers is a critical component of the FDA’s postmarket surveillance capability," the FDA said in its March 11 announcement.
By the end of May 2026, the AEMS system will contain real-time adverse event reports for all FDA-regulated products, the FDA added, noting that it processes approximately six million adverse event reports per year.
