Centers of Excellence in Regulatory Science and Innovation (CERSIs)
Extramural Regulatory Science – CERSIs
ORES manages FDA-wide programs that provide funding to support extramural regulatory science and innovation to address scientific and public health priorities.
The Centers of Excellence in Regulatory Science and Innovation (CERSI) program was established to foster robust and innovative approaches to advance regulatory science. both individually and synergistically through collaborative interactions between academia, industry, and FDA.
The CERSIs promote innovation in regulatory science predominantly through supporting cutting-edge scientific research that address high-priority regulatory science needs identified within FDA's Regulatory Science Framework. They may also provide regulatory science information sharing opportunities, such as lectures, workshops, courses, scholar awards, fellowships, and competitions.
The current CERSI institutions were selected and awarded through a competitive process for a cooperative agreement under RFA-FD-23-004. The institutions in the CERSI program received current awards starting September 1, 2023with a maximum of $50M over 5 years.
Current CERSIs
| CERSI | FDA POC | CERSI Establishment Date |
|---|---|---|
| Kristin Sepulveda | 2013 | |
| Joy Battles | 2014 | |
| University of California at San Francisco (UCSF) - Stanford University | Kristin Sepulveda | 2014 |
| Joy Battles | 2016 | |
| Tracy Chen | 2023 |
CERSI Collaborative 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
Resources For You
CERSI Regulatory Science Information Sharing Opportunities
- 2023 CERSI Program Showcase
- Workshops and Training Courses
- Lectures and Webinars
- Scholars Program
- America's Got Regulatory Science Talent Competition
Contact the Office of Regulatory and Emerging Science: ORES@fda.hhs.gov