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Clin Pharmacol Ther. 2012 Mar;91(3):380-3. doi: 10.1038/clpt.2011.318.

The critical path initiative: leveraging collaborations to enhance regulatory science.

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  • 1Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.


Since 2004, the Critical Path Initiative has prompted industry, academia, and government agencies to work together to share the information, technology, and expertise critical to modernize and transform our approach to drug development and review. Various collaborations have been sharing data in a precompetitive space, establishing data standards, and facilitating collective tool development. As a result, the organization is making progress toward developing knowledge and tools that can reduce uncertainty in medical product development.

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