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Paving the critical path of drug development: the CDER perspective

Improving the science of drug development and regulation is important in fulfilling the public health mission of the US Food and Drug Administration (FDA). A decade on from the launch of the Critical Path Initiative, the FDA's Center for Drug Evaluation and Research (CDER) is now participating in more than 20 science-driven consortia to achieve this goal.

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Acknowledgements

J.W. would like to thank A. Rowzee and H. Smith for their contributions to this article.

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Correspondence to Janet Woodcock.

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The author declares no competing financial interests.

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FURTHER INFORMATION

Accelerating Medicines Partnership

Advancing Regulatory Science for Public Health — A Framework for FDA's Regulatory Science Initiative

Advancing Regulatory Science at FDA — A Strategic Plan. 2011

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Biomarker Qualification Program

Drug Development Tools (DDT) Qualification Programs

Enhancing Benefit–Risk Assessment in Regulatory Decision-Making

Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products

I-SPY 2 TRIAL

PCORnet: The National Patient-Centered Clinical Research Network

S1400 Master Protocol

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Woodcock, J. Paving the critical path of drug development: the CDER perspective. Nat Rev Drug Discov 13, 783–784 (2014). https://doi.org/10.1038/nrd4435

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