Centers of Excellence in Regulatory Science and Innovation (CERSI)
Rapid advances in innovative science are bringing fundamental changes to the way FDA-regulated products are developed, evaluated, manufactured, and used. Evolving areas of science, like cell therapy and nanotechnology, are promising novel approaches to improving our health while demanding new ways to evaluate the safety and effectiveness of these products.
FDA's innovation initiatives, including Critical Path
and Advancing Regulatory Science
, describe how FDA is harnessing these new technologies to develop the tools, standards, and approaches required to assess the safety, efficacy, quality, and performance of innovative products. These initiatives also emphasize that bringing regulatory science into the 21st century requires the collaborative efforts of all stakeholders--including academia, industry, and other governmental agencies.
In October 2011, FDA awarded $2 million to launch Centers of Excellence in Regulatory Science and Innovation at the University of Maryland
and Georgetown University
The investment is part of FDA’s effort, outlined in the Agency's strategic plan
, to foster a robust, collaborative, regulatory science culture that enables FDA to address the scientific challenges presented by revolutions in medical product development and to improve food safety and quality.
Research, Scientific Exchanges, and Professional Development
FDA is modernizing its scientific infrastructure by enhancing its internal research
and expanding external collaborations like the Centers of Excellence, which promote cross-disciplinary regulatory science training, scientific exchanges, and research. A strong in-house contingent of scientific and technical experts proficient in cutting-edge science and technologies together with a network of collaborations is key to FDA's capacity to evaluate increasingly complex products and promote innovation that addresses unmet public health needs.
To foster continual professional development
of its doctors, nurses, and pharmacists, FDA offers them a range of opportunities, from participation in scientific meetings and conferences on cutting-edge research to collaborations with the Centers of Excellence and access to state-of-the-art science courses, workshops, and seminars. These opportunities enable FDA staff to remain engaged with the academic and medical practice community both as they develop leading-edge medical advances and use the products they regulate.
Other FDA Centers of Excellence