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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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Detaylı Bibliyografya
Yayımlandı:Clin Trials
Asıl Yazarlar: Skydel, Joshua J, Zhang, Audrey D, Dhruva, Sanket S, Ross, Joseph S, Wallach, Joshua D
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: 2021
Konular:
Online Erişim: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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