The U.S. FDA has begun daily publication of adverse event data from the agency’s Adverse Event Reporting System (FAERS), in an effort to modernize the agency’s safety monitoring infrastructure.
The FAERS database is used to collect and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and biologics. Reports are submitted by health care professionals, consumers and manufacturers.
“Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Marty Makary. “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.”
Makary has vowed to make “radical transparency” a priority for FDA communications and actions. Last month, the agency began enforcing the ICH E2B(R3) standard for electronic submission of Individual Case Safety Reports (ICSRs) to the FAERS database.