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Study
Drug manufacturers' delayed disclosure of serious and unexpected adverse events to the US Food and Drug Administration.
August 12, 2015
Ma P, Marinovic I, Karaca-Mandic P. JAMA Intern Med. 2015;175(9):1565-6.
This study examined adverse drug events reported to the FDA by manufacturers. Less than 10% of reports were delayed beyond the 15-day reporting requirement, but adverse events involving death were more likely to be delayed. This finding suggests that current regulatory policy could be optimized to promote timely reporting in all cases.
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