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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Detalles Bibliográficos
Autores principales: Skydel, Joshua J., Luxkaranayagam, Anita T., Dhruva, Sanket S., Ross, Joseph S., Wallach, Joshua D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2019
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6512282/
https://www.ncbi.nlm.nih.gov/pubmed/31074812
http://dx.doi.org/10.1001/jamanetworkopen.2019.3410

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6512282/
https://www.ncbi.nlm.nih.gov/pubmed/31074812
http://dx.doi.org/10.1001/jamanetworkopen.2019.3410

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