在后 FDAAA 时代建立药物遗传学检测的临床实用性。

Establishing clinical utility of pharmacogenetic tests in the post-FDAAA era.

机构信息

Health Law & Policy Institute and Center on Biotechnology & Law, University of Houston Law Center, Houston, Texas, USA.

出版信息

Clin Pharmacol Ther. 2010 Dec;88(6):749-51. doi: 10.1038/clpt.2010.237.

DOI:10.1038/clpt.2010.237

PMID:21081943

Abstract

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.

摘要

2007 年美国食品和药物管理局（FDA）修正案全面实施后，将在药品上市后的阶段提供新的证据来源和新的监管机制。如果巧妙而谨慎地应用这些新功能，它们可能有助于解决长期以来阻碍药物基因组学临床转化的问题。