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.
Rapid advances in innovative science are bringing fundamental changes to the way FDA-regulated products are developed, evaluated, manufactured, and used. Evolving areas of science, like cell therapy, are promising novel approaches to improving our health while demanding new ways to evaluate the safety and effectiveness of these products.
FDA's innovation initiatives, including Critical Path and Advancing Regulatory Science, describe how FDA is harnessing these new technologies to develop the tools, standards, and approaches required to assess the safety, efficacy, quality, and performance of innovative products. These initiatives also emphasize that bringing regulatory science into the 21st century requires the collaborative efforts of all stakeholders--including academia, industry, and other governmental agencies.
FDA CERSIs: University of Maryland, Georgetown University, UCSF-Stanford, and Johns Hopkins University
In October 2011, FDA awarded $2 million to launch Centers of Excellence in Regulatory Science and Innovation at the University of Maryland and Georgetown University . And in May 2014, FDA expanded its CERSI network, providing funding through a competitive application process to the University of California at San Francisco (UCSF) in a joint effort with Stanford University (UCSF-Stanford ) and Johns Hopkins University . The investment is part of FDA's effort, outlined in the Agency's strategic plan, to foster a robust, collaborative, regulatory science culture that enables FDA 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
FDA is modernizing its scientific infrastructure by enhancing its internal research and expanding external collaborations like the CERSIs. A strong in-house contingent of scientific and technical experts proficient in cutting-edge science and technologies 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.
To foster continual professional development of its doctors, nurses, and pharmacists, FDA offers them a range of opportunities, from participation in scientific meetings and conferences on cutting-edge research to collaborations with the Centers of Excellence and access to state-of-the-art science courses, workshops, and seminars. These opportunities enable FDA staff to remain engaged with the academic and medical practice community both as they develop leading-edge medical advances and use the products they regulate.
FDA's Centers of Excellence partners are critical to Agency efforts to promote faster and better scientific approaches to advancing regulatory science so that products get to the people who need them when they need them. The University of Maryland, Georgetown University, UCSF-Stanford, and Johns Hopkins are working closely with FDA on projects related to specific priority areas in FDA's Strategic Plan to improve public health.