alexa The FDA critical path initiative and its influence on new drug development.
Biomedical Sciences

Biomedical Sciences

Journal of Biomedical Engineering and Medical Devices

Author(s): Woodcock J, Woosley R

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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. This article was published in Annu Rev Med and referenced in Journal of Biomedical Engineering and Medical Devices

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