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The FDA critical path initiative and its influence on new drug development.
Annual Review of Medicine ( IF 10.5 ) Pub Date : 2008-01-12 , DOI: 10.1146/annurev.med.59.090506.155819
Janet Woodcock 1 , Raymond Woosley
Affiliation  

Societal expectations about drug safety and efficacy are rising while productivity in the pharmaceutical industry is falling. In 2004, the US Food and Drug Administration introduced the Critical Path Initiative with the intent of modernizing drug development by incorporating recent scientific advances, such as genomics and advanced imaging technologies, into the process. An important part of the initiative is the use of public-private partnerships and consortia to accomplish the needed research. This article explicates the reasoning behind the Critical Path Initiative and discusses examples of successful consortia.

中文翻译:

FDA关键路径计划及其对新药开发的影响。

社会对药物安全性和功效的期望正在上升,而制药业的生产率却在下降。2004年,美国食品和药物管理局(FDA)引入了关键路径计划(Critical Path Initiative),目的是通过将基因组学和先进的成像技术等最新科学进展纳入该过程,实现药物开发的现代化。该计划的重要部分是利用公私伙伴关系和财团来完成所需的研究。本文阐述了“关键路径倡议”背后的理由,并讨论了成功财团的例子。
更新日期:2019-11-01
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