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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Dades bibliogràfiques
Publicat a:JAMA Netw Open
Autors principals: Skydel, Joshua J., Luxkaranayagam, Anita T., Dhruva, Sanket S., Ross, Joseph S., Wallach, Joshua D.
Format: Artigo
Idioma:Inglês
Publicat: American Medical Association 2019
Matèries:
Original Investigation
Accés en línia: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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