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Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period

BACKGROUND: The purpose of this study was to describe the experience of the Center of Drug Evaluation and Research (CDER) with expanded access of investigational drugs. METHODS: Multiple searches of CDER’s document tracking system were performed to identify the number, type, and indication for all e...

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Detalhes bibliográficos
Publicado no:Ther Innov Regul Sci
Main Authors: Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Khozin, Sean, Moscicki, Richard
Formato: Artigo
Idioma:Inglês
Publicado em: 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5135086/
https://ncbi.nlm.nih.gov/pubmed/27917324
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479016656030
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