FDA now providing daily updates on adverse events

The U.S. Food and Drug Administration is now providing real-time, daily publication updates on adverse event data from its reporting system.

In an effort to modernize and provide transparency on public health, the agency announced at the end of last week that adverse event data from the FDA Adverse Event Reporting System (FAERS) will be published daily. Previously, updates were published on a quarterly basis.

“People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public,” FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. “We’re closing that waiting period and will continue to streamline the process from start to finish.”

The FAERS contains reports from health care professionals, consumers, and manufacturers on adverse events, serious medication errors, and product quality complaints for prescription drugs and biologics. The public can access the data on the FAERS Public Dashboard. According to the FDA, the agency receives more than 2 million reports on adverse events and medication error reports each year.

The shift to daily publication is part of “the FDA’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 agency writes in a press release.

The FDA encourages both health care professionals and the public to report any adverse events with human medical products on the FDA MedWatch website.

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