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The FDA’s Experience with Emerging Genomics Technologies—Past, Present, and Future

The rapid advancement of emerging genomics technologies and their application for assessing safety and efficacy of FDA-regulated products require a high standard of reliability and robustness supporting regulatory decision-making in the FDA. To facilitate the regulatory application, the FDA implemen...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Xu, Joshua, Thakkar, Shraddha, Gong, Binsheng, Tong, Weida
Formato: Artigo
Idioma:Inglês
Publicado em: 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4973466/
https://ncbi.nlm.nih.gov/pubmed/27116022
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-016-9917-y
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