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Translating New Science Into the Drug Review Process: The US FDA’s Division of Applied Regulatory Science

In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulato...

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Detalles Bibliográficos
Autores principales: Rouse, Rodney, Kruhlak, Naomi, Weaver, James, Burkhart, Keith, Patel, Vikram, Strauss, David G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5844453/
https://www.ncbi.nlm.nih.gov/pubmed/29568713
http://dx.doi.org/10.1177/2168479017720249