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Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety
BACKGROUND: The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of patients receiving investigational drugs under expanded access. METHODS: To better define FDA’s role in the review of requests for expanded access, multiple queries o...
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| Publicado no: | Ther Innov Regul Sci |
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| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5443559/ https://ncbi.nlm.nih.gov/pubmed/28553566 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479016679214 |
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