August 22, 2025
1 min read
Key takeaways:
- The FDA Adverse Event Reporting System will now host daily publications, instead of quarterly.
- The agency’s goal is to streamline the adverse event reporting process.
The FDA has started reporting real-time data about adverse events through the FDA Adverse Event Reporting System, improving transparency and quickening the protection of public health, according to a press release from the agency.
The reports for the FDA Adverse Event Reporting System (FAERS) were previously published quarterly, according to the FDA.
The FDA has started reporting real-time data about adverse events through the FDA Adverse Event Reporting System.
The agency hopes to speed up the identification of safety signals by modernizing its data collection and safety monitoring infrastructure. This includes strategies such as increasing the frequency of adverse event reporting across all its systems.
“Adverse event reporting should be fast, seamless and transparent,” FDA Commissioner Martin Makary, MD, MPH said in the release. “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 agency’s primary database. It collects and analyzes adverse event reports as well as significant medication errors and quality complaints from health care professionals, consumers and manufacturers about prescription drugs and biologics.
The FDA encourages consumers and health care professionals to report adverse events through the MedWatch website. The most recent adverse events reports can be viewed on the FAERS Public Dashboard.
