FDA Begins Real-time Reporting of Adverse Event Data

The US FDA has begun daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS). This represents a significant step forward in modernizing the agency’s safety monitoring infrastructure and demonstrates its commitment to radical transparency and real-time protection of public health, the agency says.

“Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Marty Makary, MD, MPH. “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish.”

FAERS is the FDA’s primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics, containing reports submitted by healthcare professionals, consumers, and manufacturers.

The shift is one of many steps in the FDA’s broader data modernization strategy to streamline all of its reporting systems and increase reporting frequency across all systems to identify safety signals faster.