The U.S. Food and Drug Administration today (Oct. 26) announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).
The centers, which will be located at the University of Maryland and Georgetown University, 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.
In August 2011, the agency released the strategic plan for: “Advancing Regulatory Science at FDA."
More recently, the agency announced a related innovation initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.”
“These partnerships represent a critical, necessary and creative investment - one that will benefit not just FDA and academia, but also American consumers and industry,” said FDA Chief Scientist Jesse L. Goodman, M.D., M.P.H. “The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions.”
Working closely with FDA scientists, CERSI researchers will assist the FDA in driving innovation in medical product development as well as in advancing laboratory, population, behavioral, and manufacturing sciences. The agency chose to pilot the CERSIs in the Washington, D.C. area, to allow for the greatest possible face-to-face collaboration and training with FDA staff.
“These partnerships will promote faster and better scientific approaches to product development, helping people in need and supporting biotech innovation,” Goodman said.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
