Office of Clinical Pharmacology, Center for Drug Evaluation & Research, US FDA, HFD-850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Pharmacogenomics. 2010 Apr;11(4):507-12. doi: 10.2217/pgs.10.16.
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.
在过去的 10 年中，美国食品和药物管理局（FDA）作为其保护和促进公共健康使命的一部分，已经成为强大的药物基因组学倡导者，通过推动创新使药物更安全、更有效。该机构在基于科学信息的基础上谨慎地倡导了其倡议，这些信息来自于新颖的项目，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非凡进展的谨慎监管评估，这些进展支持了药物标签中遗传信息的更新。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，并且它们将继续发展，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 年内继续成熟为医学实践必不可少的科学。
