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The FDA and genetic testing: improper tools for a difficult problem
The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Oxford University Press
2015
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5033563/ https://www.ncbi.nlm.nih.gov/pubmed/27774193 http://dx.doi.org/10.1093/jlb/lsv002 |