Establishing Clinical Utility of Pharmacogenetic Tests in the Post-FDAAA Era

被引:6
作者
Evans, B. J. [1 ,2 ]
机构
[1] Univ Houston, Ctr Law, Hlth Law & Policy Inst, Houston, TX 77004 USA
[2] Univ Houston, Ctr Law, Ctr Biotechnol & Law, Houston, TX 77004 USA
关键词
D O I
10.1038/clpt.2010.237
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The US Food and Drug Administration (FDA) Amendments Act of 2007, when fully implemented, will offer new sources of evidence and new regulatory mechanisms during the postmarket phase of drug life. If artfully and carefully applied, these new capabilities could help resolve problems that have long impeded the clinical translation of pharmacogenomics.
引用
收藏
页码:749 / 751
页数:3
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