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  1. Advancing Regulatory Science

Centers of Excellence in Regulatory Science and Innovation (CERSIs)

 Johns Hopkins CERSI  Univ. of California San Francisco-Stanford University CERSI  University of Maryland CERSI  Yale University-Mayo 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, training, 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, UCSF-Stanford, Johns Hopkins University, and Yale-Mayo Clinic

FDA CERSIs at the University of MarylandUniversity 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 tobacco use.

Research, Scientific Exchanges, and Training

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.

CERSI Steering Committee, Research Priority Areas and Metrics

The FDA Steering Committee for the CERSIs provides advice and guidance to FDA's Office of Regulatory Science and Innovation that established the CERSI program and to the CERSI academic institutions to ensure that relevant issues and activities are effectively communicated to FDA leadership and staff.

Through the CERSIs, FDA offers its scientific staff a range of opportunities, including research collaborations and access to regulatory science-related training, workshops, and seminars. These opportunities support FDA staff engagement with the academic and medical communities in areas of mutual interest in regulatory science.

FDA has developed metrics to assess the impact of CERSI research and identified priority areas, based on the agency's current unmet regulatory science needs.

CERSI Research Projects

CERSI Publications

CERSI Training and Education Activities

Resources For You

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