The FDA and Genomic Tests - Getting Regulation Right

The FDA and Genomic Tests - Getting Regulation Right
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DOI:
10.1056/nejmsr1501194
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发表时间:
2015-06-04
影响因子:
158.5
通讯作者:
Jarvik, Gail P.
Jarvik, Gail P.
中科院分区:
医学1区
文献类型:
--
作者:
Evans, Barbara J.;Burke, Wylie;Jarvik, Gail P.

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作者回顾了FDA关于下一代测序和临床医学实验室开发测试监管提案的本质,并就保护消费者和促进创新提出了一些想法。
The authors review the nature of the proposal by the FDA for the regulation of next-generation sequencing and laboratory-developed tests in clinical medicine and offer thoughts on what is needed to protect consumers and foster innovation.