WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has begun publishing adverse event data from the FDA Adverse Event Reporting System (FAERS) on a daily basis, marking a major shift toward greater transparency and real-time monitoring of potential safety risks tied to prescription drugs and therapeutic biologics.
The move, announced Friday, reflects the FDA’s ongoing modernization efforts to strengthen its safety monitoring infrastructure and accelerate public access to critical health information. FAERS serves as the agency’s primary database for collecting and analyzing reports of adverse events, serious medication errors, and product quality complaints. Reports are submitted by healthcare providers, patients, and drug manufacturers.
FDA Commissioner Marty Makary, M.D., M.P.H., emphasized the importance of faster public access to data, stating that adverse event reporting “should be fast, seamless and transparent.” He noted that the agency is reducing delays that previously forced the public to wait months for updated information, ensuring quicker detection and response to emerging safety signals.
The change is part of a broader FDA data modernization strategy aimed at streamlining adverse event reporting systems and improving reporting frequency across all platforms. By updating FAERS daily, the agency intends to identify potential risks more rapidly, enabling earlier interventions to protect public health.
Healthcare professionals and consumers are encouraged to report adverse events through the FDA’s MedWatch program. The updated information is accessible via the FAERS Public Dashboard, providing the public with unprecedented near real-time insights into reported safety concerns.
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