Journal Article

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

Moore TJ, Furberg CD, Mattison DR, et al. Pharmacoepidemiology and drug safety. 2016;25:713-8.

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.