FDA Establishes Two Centers for Regulatory Science - - BioPharm International

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FDA Establishes Two Centers for Regulatory Science


BioPharm Bulletin

On Oct. 26, 2011, FDA dedicated $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 at Georgetown University, will focus on the scientific knowledge and training needed to modernize and improve the ways the agency reviews and evaluates drugs and medical devices.

“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 in a press release. “The Centers of Excellence will create new scientific research, training, and staff-exchange opportunities for FDA and leading area institutions.”

CERSI researchers will cooperate with FDA scientists to stimulate innovation in medical-product development. The scientists also will aim to advance laboratory, population, behavioral, and manufacturing sciences. FDA chose to pilot the CERSI in the Washington, DC, area to allow for face-to-face collaboration and training with FDA staff.

FDA defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. For the past year, the agency has focused on improving regulatory science by launching various initiatives. Earlier this month, FDA launched an initiative titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.” The initiative is an effort to increase the number of new-drug submissions by bringing stakeholders together to identify and overcome the challenges of product development and assessment.

In August 2011, FDA released its “Strategic Plan for Regulatory Science,” which describes the agency’s intent to improve the process for developing and evaluating new products from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology. It also emphasizes FDA’s intention to study and improve how it communicates health information to consumers.

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