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  1. Advancing Regulatory Science

Centers of Excellence in Regulatory Science and Innovation (CERSIs)


The Centers of Excellence in Regulatory Science and Innovation (CERSI) program was established to foster robust and innovative approaches to advance regulatory science, and the goal is for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the Office of Regulatory Science and Innovation (ORSI), through collaborative interactions with FDA scientific experts and funding offices.

The CERSIs promote innovation in regulatory science predominantly through cutting-edge scientific research that supports FDA's regulatory science needs. They may also provide regulatory science information sharing opportunities, such as lectures, workshops, courses, scholar awards, fellowships, and competitions. We aim for the collaborative activities to target one or more of the focus areas in the Regulatory Science Framework.

ORSI is pleased to announce several renewal awards and one new award for the CERSI Program. The institutions were selected and awarded through a competitive process for a cooperative agreement under RFA-FD-23-004. Renewal awards were made to University of MarylandJohns Hopkins University, Yale University in joint effort with Mayo Clinic, and University of California at San Francisco (UCSF) in a joint effort with Stanford University (UCSF-Stanford). A new award was made to the University of North Carolina, Chapel Hill, in a partnership with Duke University. The new Research Triangle CERSI also plans to partner with North Carolina State University and North Carolina Central University, a historically black college and university (HBCU) on research projects and regulatory science information sharing opportunities. The institutions in the CERSI program received awards starting September 1, 2023 for up to $50M for 5 years.


CERSI Research Projects

FDA has developed Outcomes of Interest for Regulatory Science Research Projects. which will be used to assess the contributions/impact of the CERSI program.

CERSI Publications

CERSI Regulatory Science Information Sharing Opportunities

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