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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...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Argitaratua izan da:Ther Innov Regul Sci
Egile Nagusiak: Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Lowy, Naomi
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: 2017
Gaiak:
Sarrera elektronikoa: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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