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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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Enregistré dans:
Détails bibliographiques
Publié dans:Clin Trials
Auteurs principaux: Skydel, Joshua J, Zhang, Audrey D, Dhruva, Sanket S, Ross, Joseph S, Wallach, Joshua D
Format: Artigo
Langue:Inglês
Publié: 2021
Sujets:
Accès en ligne: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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