Medical Innovation Exchange

FDA Announces Center of Excellence in Regulatory Science Award Recipients



The FDA, Office of Regulatory Science & Innovation (OCS/ORSI) announced several renewal awards and one new award for the Centers of Excellence in Regulatory Science & Innovation (CERSI) Program. The CERSI program was established to foster robust and innovative approaches to advance regulatory science through collaborative interactions with FDA scientific experts. 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. When selecting awardees, the agency aims for the collaborative activities to target one or more of the focus areas in the Regulatory Science Framework:

  • Modernize development and evaluation of FDA-regulated products
  • Strengthen post-market surveillance labeling of FDA-regulated products
  • Investigate public health preparedness and response of FDA, patients and consumers

Institutions are selected and awarded through a competitive process for a cooperative agreement under RFA-FD-23-004. Renewal awards were made to:

  • University of Maryland
  • Johns Hopkins University
  • Yale University in a partnership with Mayo Clinic
  • University of California, San Francisco, in a partnership with Stanford University

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 up to $50M for five years.

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