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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...
Autores principales: | Rouse, Rodney, Kruhlak, Naomi, Weaver, James, Burkhart, Keith, Patel, Vikram, Strauss, David G. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2017
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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 |
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