The U.S. Food and Drug Administration has started releasing reports of adverse events linked to prescription drugs and biologic products on a daily basis, ending its long-standing practice of updating the FDA Adverse Event Reporting System once every quarter. The change, effective 22 Aug. 2025, marks the first time the database will operate in near real time. Commissioner Marty Makary said the move is intended to make safety information “fast, seamless and transparent,” adding that patients and clinicians should not “have to wait months” for data that could influence therapeutic decisions. The agency hopes the accelerated cadence will help health professionals detect signals earlier and refine post-market risk assessments. The daily releases form part of a broader modernization push by Makary and Health Secretary Robert F. Kennedy Jr., who have pledged to harness electronic health records and other digital tools to improve surveillance of drugs, biologics and vaccines. The FDA is also exploring additional refinements to its dashboards to make the information easier to analyze. Market analysts note that the faster flow of safety reports could heighten short-term volatility in pharmaceutical and biotechnology stocks, as potentially negative signals will become visible to investors more quickly. The FDA emphasized, however, that the presence of an event report does not, by itself, establish that a medicine caused the reaction.
The @US_FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a quarterly basis. #fda #biopharma #biospace https://t.co/9YTxjO9b5S
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