The US Food and Drug Administration (FDA) announced it began daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS). 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 health care professionals, consumers, and manufacturers.
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 FDA said in a press release. “Adverse event reporting should be fast, seamless and transparent,” explained 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.”
According to the FDA, the shift is one of many steps in the agency’s broader data modernization strategy to streamline all of its adverse event reporting systems and increase reporting frequency across all systems to identify safety signals faster.
The public can view the latest adverse event data on the FAERS Public Dashboard. The FDA said encourages health care professionals and consumers to report adverse events to the FDA’s MedWatch site.