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

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.

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Detalhes bibliográficos
Publicado no:JAMA Intern Med
Main Authors: Tau, Noam, Shochat, Tzippy, Gafter-Gvili, Anat, Tibau, Ariadna, Amir, Eitan, Shepshelovich, Daniel
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2019
Assuntos:
Research Letter
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6724416/
https://ncbi.nlm.nih.gov/pubmed/31479104
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2019.3066
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