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Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified...

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Detalhes bibliográficos
Publicado no:Genomics Inform
Main Authors: Yim, Seon-Hee, Chung, Yeun-Jun
Formato: Artigo
Idioma:Inglês
Publicado em: Korea Genome Organization 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4330248/
https://ncbi.nlm.nih.gov/pubmed/25705152
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.5808/GI.2014.12.4.151
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