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New and incremental FDA black box warnings from 2008 to 2015

BACKGROUND: The boxed warning (also known as ‘black box warning [BBW]’) is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drug...

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Detalhes bibliográficos
Publicado no:Expert Opin Drug Saf
Main Authors: Solotke, Michael T., Dhruva, Sanket S., Downing, Nicholas S., Shah, Nilay D., Ross, Joseph S.
Formato: Artigo
Idioma:Inglês
Publicado em: 2017
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6013049/
https://ncbi.nlm.nih.gov/pubmed/29215916
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/14740338.2018.1415323
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