Some adverse drug events not reported by manufacturers to FDA by 15-day mark

http://www.eurekalert.org/pub_releases/2015-07/tjnj-sad072315.php

Public Release: 27-Jul-2015
The JAMA Network Journals

About 10 percent of serious and unexpected adverse events are not reported by drug manufacturers to the U.S. Food and Drug Administration under the 15-day timeframe set out in federal regulations, according to an article published online by JAMA Internal Medicine.

Health care professionals and consumers can voluntarily report adverse drug events directly to the FDA or the drug manufacturer. Adverse events that are serious (including death, life-threatening, hospitalization, disability and birth defects) and unexpected (any adverse experience not listed in the current labeling) are classified as "expedited" and manufacturers receiving such reports are mandated to forward them to the FDA "as soon as possible but in no case later than 15 calendar days of the initial receipt of the information" under federal regulation, according to background information in the research letter.

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