Association Between Data Sources and US Food and Drug Administration Drug Safety Communications.
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- Record sourced from PubMed, PMID 31479104.
- Also identified by DOI 10.1001/jamainternmed.2019.3066 and PMC identifier 6724416.
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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.