Healthy Skepticism Library item: 12447

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Woodcock J, Woosley R.
The FDA critical path initiative and its influence on new drug development.
Annu Rev Med 2008; 59:1-12:
http://arjournals.annualreviews.org/doi/abs/10.1146/annurev.med.59.090506.155819

Abstract:

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.