DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA
DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA
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DOI：
10.2217/pgs.10.16
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发表时间：
2010-04-01
期刊：
影响因子：
2.1
通讯作者：
Zineh, Issam
中科院分区：
文献类型：
--
作者：
Lesko, Lawrence J.;Zineh, Issam
在过去的10年里，美国FDA已经成为一个强有力的药物基因组学倡导者，作为其使命的一部分，通过实现使药物使用更安全和更有效的创新来保护和促进公共健康。该机构谨慎地发展了其倡导，其基础是来自新项目的基于科学的信息，例如自愿基因组学数据提交倡议，以及对临床药物基因组学的非凡进展进行仔细的监管评估，这些进展支持用遗传信息更新药物标签。本评论详细介绍了这些成就的演变。然而，药物基因组学仍然面临许多挑战，它们将继续发展，所有利益相关者必须共同努力。随着这十年的结束，我们提出了四个需要共同解决的主要领域，以确保药物基因组学在未来10年内继续成熟，成为一门对医学实践至关重要的科学。
Over the past 10 years, the US FDA has become a strong pharmacogenomics advocate as part of its mission to both protect and advance public health by enabling innovations that make medicines safer to use and more effective. The agency has evolved its advocacy cautiously on a foundation of science-based information from novel programs, such as the Voluntary Genomics Data Submission initiative, and on careful regulatory assessment of the extraordinary advances in clinical pharmacogenomics that have supported the update of drug labels with genetic information. This commentary goes into detail on the evolution of these achievements. However, many challenges remain for pharmacogenomics, and they will continue to evolve, and all stakeholders must work together. As the decade draws to a close, we have presented four major areas that need to be addressed collectively to assure that pharmacogenomics continues to mature over the next 10 years into a science that is essential to the practice of medicine.