Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. | AHRQ Patient Safety Network

Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. | AHRQ Patient Safety Network

• Study
 
• Published February 2016

Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.

Moore TJ, Furberg CD, Mattison DR, Cohen MR. Pharmacoepidemiol Drug Saf. 2016 Feb 10; [Epub ahead of print].

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.

PubMed citationAvailable at

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