Examining the Use of Real‐World Evidence in the Regulatory Process

The 21st Century Cures Act passed by the United States Congress mandates the US Food and Drug Administration to develop guidance to evaluate the use of real‐world evidence (RWE) to support the regulatory process. RWE has generated important medical discoveries, especially in areas where traditional...

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Vydáno v:Clin Pharmacol Ther
Hlavní autoři: Beaulieu‐Jones, Brett K., Finlayson, Samuel G., Yuan, William, Altman, Russ B., Kohane, Isaac S., Prasad, Vinay, Yu, Kun‐Hsing
Médium: Artigo
Jazyk:Inglês
Vydáno: John Wiley and Sons Inc. 2019
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On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC7093234/
https://ncbi.nlm.nih.gov/pubmed/31562770
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.1658
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