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Real-world evidence and regulatory drug approval.
Nature Reviews Clinical Oncology ( IF 78.8 ) Pub Date : 2020-05-01 , DOI: 10.1038/s41571-020-0345-7
Michael J Raphael 1, 2, 3 , Bishal Gyawali 1, 2, 3, 4 , Christopher M Booth 1, 2, 3
Affiliation  

The FDA has demonstrated a willingness to expedite access to new cancer medicines by using real-world evidence to support regulatory drug approval. In this article, we explore three recent examples of such approvals and the lessons that can be learned from this collective experience.

中文翻译:

真实证据和监管药物批准。

FDA已经表明愿意通过使用现实世界的证据来支持监管性药物批准来加快新癌症药物的获取。在本文中,我们将探讨三个最近的此类批准示例,以及可以从集体经验中学到的教训。
更新日期:2020-02-28
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