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US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018

BACKGROUND/AIMS: The US Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics (“therapeutics”). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics...

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Detalhes bibliográficos
Publicado no:Clin Trials
Main Authors: Skydel, Joshua J, Zhang, Audrey D, Dhruva, Sanket S, Ross, Joseph S, Wallach, Joshua D
Formato: Artigo
Idioma:Inglês
Publicado em: 2021
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8292154/
https://ncbi.nlm.nih.gov/pubmed/33863236
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/17407745211005044
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