Hinman Lois, Spear Brian, Tsuchihashi Zenta, Kelly James, Bross Peter, Goodsaid Federico, Kalush Francis
Novartis Pharmaceuticals Corp, One Health Plaza, East Hanover, NJ 07939-1080, USA.
Pharmacogenomics. 2009 Jan;10(1):127-36. doi: 10.2217/14622416.10.1.127.
The 4th US FDA/Industry Workshop on Pharmacogenomics in Drug Development and Regulatory Decision Making, was held in MD, USA, on December 10-12, 2007. One of the breakout sessions of the workshop focused on the regulatory issues around codevelopment of drugs and companion diagnostics. This session used hypothetical case studies as focal points for discussion of current thought and critical issues for both industry and the FDA in this evolving field. The panel and the audience discussed the evolution of the FDA's thinking on the regulatory path for companion diagnostics since the release of the April 2005 draft Drug Test Codevelopment Concept Paper and the issues faced by industry in attempting codevelopment efforts. This session provided an opportunity to allow an exchange of ideas between the FDA and industry and to identify critical issues that need further discussion in this important and evolving field.
2007年12月10日至12日，第四届美国食品药品监督管理局（FDA）/制药行业药物基因组学在药物研发与监管决策中的应用研讨会在美国马里兰州举行。研讨会的一场分组会议聚焦于药物与伴随诊断试剂联合开发的监管问题。该会议以假设的案例研究为讨论焦点，探讨了这一不断发展的领域中行业界和FDA当前的想法及关键问题。专家小组和与会人员讨论了自2005年4月发布《药物测试联合开发概念文件》草案以来，FDA在伴随诊断试剂监管路径上的思路演变，以及行业界在尝试进行联合开发工作时所面临的问题。本次会议为FDA与行业界之间交流想法提供了契机，并明确了在这一重要且不断发展的领域中需要进一步讨论的关键问题。
