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Study
Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.
April 6, 2016
Moore TJ, Furberg CD, Mattison DR, et al. Pharmacoepidemiol Drug Saf. 2016;25(6):713-8.
According to this study, many adverse drug event reports submitted by drug manufacturers to the Food and Drug Administration were incomplete. The authors advocate for the FDA to update their reporting requirements and compliance policies.
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