Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments

IMPORTANCE: The US Food and Drug Administration (FDA) can use postmarketing requirements to mandate pharmaceutical companies to conduct clinical trials after the approval of novel therapeutics. Pharmaceutical companies can also agree to conduct nonmandated clinical trials as postmarketing commitment...

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Detalhes bibliográficos
Publicado no:JAMA Netw Open
Main Authors: Skydel, Joshua J., Luxkaranayagam, Anita T., Dhruva, Sanket S., Ross, Joseph S., Wallach, Joshua D.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2019
Assuntos:
Original Investigation
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6512282/
https://ncbi.nlm.nih.gov/pubmed/31074812
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamanetworkopen.2019.3410
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