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FDA awards Georgetown University a Center of Excellence in Regulatory Science & Innovation
Date:10/26/2011

WASHINGTON, D.C. -- Georgetown University today announces a partnership with the U.S. Food and Drug Administration (FDA) to establish a first of its kind Center of Excellence in Regulatory Science and Innovation (CERSI). The Center is supported by an FDA investment with an initial $1 million grant, which is potentially part of a three-year funding program for improving drug development and manufacturing.

Experts in science, medicine and law at Georgetown University Medical Center (GUMC) and Georgetown University Law Center will lead the CERSI. Ira Shoulson, M.D., professor of neurology and director of GUMC's Program for Regulatory Science and Medicine, is principal investigator of the CERSI. Co-principal investigators include Kenneth L. Dretchen, Ph.D., professor and chairman of pharmacology and physiology at GUMC, and Lawrence Gostin, the Linda D. and Timothy J. O'Neill Professor of Global Health Law at the Law Center.

The CERSI will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA as outlined in its strategic plan for "Advancing Regulatory Science at FDA." Working closely with FDA scientists, Georgetown CERSI researchers will assist the FDA with advancing laboratory, population, behavioral, computational and manufacturing sciences, to increase the efficiency of quality medical product development.

"The CERSI award provides us with an enormous opportunity to interact collegially and productively with FDA scientists and engage our students, staff and faculty in scientific applications as we strive for more effective product development and evaluation," says Shoulson. "It will further enable us to interface substantively with the FDA to share in education, training, professional development and scientific exchange, as well as fostering innovation and applied research toward unmet public health needs."

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Contact: Karen Mallet
km463@georgetown.edu
Georgetown University Medical Center
Source:Eurekalert

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