Analyzing FDA's approaches to using electronic health record and medical claims data to support regulatory decision making

In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions. The draft guidance provides recommendations for sponsors regarding the use of real-world data in conducting studies. It also addresses...

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Bibliografiske detaljer

Principais autores:	Ksenia S. Radaeva, M. V. Pchelintsev
Format:	Artigo
Sprog:	Russo
Udgivet:	Publishing House OKI 2023-10-01
Serier:	Реальная клиническая практика: данные и доказательства
Fag:	guidelines real-world data electronic health records ehr rwd fda
Online adgang:	https://www.myrwd.ru/jour/article/view/45
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