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In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions. The draft guidance provides recommendations for sponsors regarding the use of real-world data in conducting studies.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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| Principais autores: | , |
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| Formato: | Artigo |
| Idioma: | Russo |
| Publicado em: |
Publishing House OKI
2023-10-01
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| coleção: | Реальная клиническая практика: данные и доказательства |
| Assuntos: | |
| Acesso em linha: | https://www.myrwd.ru/jour/article/view/45 |
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