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FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals

BACKGROUND: Structured, descriptive approaches are utilized by drug regulatory agencies to support and communicate approval decisions about human drugs and biologics. The US Food and Drug Administration (FDA) uses the Benefit–Risk Framework (BRF), which has been integrated into its drug review proce...

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Detalhes bibliográficos
Publicado no:Ther Innov Regul Sci
Main Authors: Lackey, Leila, Thompson, Graham, Eggers, Sara
Formato: Artigo
Idioma:Inglês
Publicado em: 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7785646/
https://ncbi.nlm.nih.gov/pubmed/32779045
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s43441-020-00203-6
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