How the Critical Path Initiative Addresses CDER's Regulatory Science Needs: Some Illustrative Examples

Therapeutic Innovation & Regulatory Science
Mark Geanacopoulos, Ruth Barratt

Abstract

Since 2008, the Critical Path Initiative has supported FDA's program of intramural research projects in regulatory science, with the goal of improving translation of advances in emerging sciences to the development of safe and effective medical products. Since 2011, the research of FDA's Center for Drug Evaluation and Research (CDER), including the work supported by the Critical Path Initiative, has been guided by the regulatory science needs identified in the CDER science and research needs report. In this review, the authors highlight a few of CDER'S Critical Path Initiative research projects, each addressing a different regulatory science need, to illustrate the diversity of regulatory science at CDER. They also describe elements common to these research projects, including broad collaboration with external partners, an increasing dependence on large data sets and computational models, and requirements for resources or perspectives specific to FDA.

References

Dec 31, 2011·Journal of Pharmaceutical and Biomedical Analysis·Connie M Gryniewicz-RuzickaJohn F Kauffman
Apr 5, 2012·Clinical Pharmacology and Therapeutics·R LeongG J Burckart
Dec 18, 2013·Clinical Pharmacology and Therapeutics·L JohannesenD G Strauss
Feb 12, 2015·Clinical Pharmacology and Therapeutics·A ParekhJ Woodcock
Mar 13, 2015·Journal of Pharmaceutical Sciences·Cyrus D AgarabiErik K Read

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Citations

Jul 1, 2015·Therapeutic Innovation & Regulatory Science·Stephen P Spielberg

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Methods Mentioned

BETA
X-ray
Glycosylation
nuclear magnetic resonance

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