Association Between Data Sources and US Food and Drug Administration Drug Safety Communications.

Tau, Noam; Shochat, Tzippy; Gafter-Gvili, Anat; Tibau, Ariadna; Amir, Eitan; Shepshelovich, Daniel · JAMA Intern Med · 2019

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Abstract

This study describes sources of initial safety signals that that preceded US Food and Drug Administration (FDA) drug safety communications and examines their associations with drug characteristics and subsequent label changes.