AHRQ Patient Safety Network ► Drug manufacturers' delayed disclosure of serious and unexpected adverse events to the US Food and Drug Administration.

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Drug manufacturers' delayed disclosure of serious and unexpected adverse events to the US Food and Drug Administration.

Ma P, Marinovic I, Karaca-Mandic P. JAMA Intern Med. 2015 Jul 27; [Epub ahead of print].

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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