FDA Begins Daily Publication of Adverse Event Data to Boost Drug Safety Oversight
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5 Articles
The FDA’s Drug Adverse Event Database Is Now Updated in Real Time: Here’s How to Use It - MedShadow Foundation | Independent Health & Wellness Journalism
On Friday, August 22, the Food and Drug Administration (FDA) announced in a press release that it would begin updating its Adverse Events Reporting System (FAERS) in real time, replacing the agency’s previous quarterly update schedule. The agency said the change “demonstrates [the FDA’s] commitment to radical transparency and real-time protection of public health.” Patients, doctors, and even family members can submit reports directly to the FAE…
REPATHA® NOW INDICATED FOR ADULTS AT INCREASED RISK FOR MAJOR ADVERSE CARDIOVASCULAR EVENTS DUE TO UNCONTROLLED LDL-C
THOUSAND OAKS, Calif., Aug. 25, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE)…
FDA to Begin Publishing Adverse Event Data Daily
With the goal of modernizing safety oversight, the FDA said it will begin publishing adverse event data from the FDA Adverse Event Reporting System (FAERS) on a daily basis. “Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Marty Makary, MD, MPH. “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 …
FDA Begins Daily Publication of Adverse Event Data to Boost Drug Safety Oversight
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 infrastr…
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