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...

Täydet tiedot

Tallennettuna:
Bibliografiset tiedot
Julkaisussa:JAMA Netw Open
Päätekijät: Skydel, Joshua J., Luxkaranayagam, Anita T., Dhruva, Sanket S., Ross, Joseph S., Wallach, Joshua D.
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: American Medical Association 2019
Aiheet:
Original Investigation
Linkit: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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