Centers of Excellence in Regulatory Science and Innovation (CERSI)

FDA's Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborations between FDA and academic institutions to advance regulatory science through innovative research, education, and scientific exchanges. Evolving areas of science are promising new approaches to improving our health while demanding new ways to evaluate the safety and effectiveness of the products FDA regulates. FDA’s Strategic Plan for Advancing Regulatory Science describes how FDA is harnessing these new technologies in collaboration with academia, industry, and other governmental agencies to develop the tools, standards, and approaches required to assess the safety, efficacy, quality, and performance of innovative products.

FDA CERSIs: University of Maryland, Georgetown University, UCSF-Stanford, Johns Hopkins University, and Yale-Mayo Clinic

FDA CERSIs at the University of Maryland, Georgetown University, University of California at San Francisco(UCSF) in a joint effort with Stanford University (UCSF-Stanford), Johns Hopkins University, and Yale University in joint effort with Mayo Clinic are part of FDA efforts to foster a robust, collaborative, regulatory science culture 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

A strong in-house contingent of scientific and technical experts proficient in cutting-edge science 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. Through the CERSIs, FDA offers its scientific staff a range of opportunities, including research collaborations and access to state-of-the-art science courses, workshops, and seminars. These opportunities support FDA staff engagement with the academic and medical communities in areas of mutual interest in regulatory science.