About Us

Our CERSI leverages the geographic proximity and extensive relationship between Johns Hopkins and the FDA and uses this as a foundation to promote a programmatic focus on three priority areas for the agency: improving clinical studies and evaluation; strengthening the social and behavioral sciences to support informed decisions; and developing a new prevention-focused food safety system. 

In addition to a strong foundation of collaboration with the Agency, our partnership also has many other strengths, including: internationally renowned scholarship in regulatory science; innovative training through online platforms harnessing modern technologies; a nimble and organic operational approach; and the potential for self-sustaining programs that will continue to serve the FDA’s strategic mission during the decades to come.

Man inspecting equipment

Regulatory Science and the FDA

During the past decade the FDA has made great strides in strengthening the breadth and rigor of its regulatory science activities.  Such achievements have been motivated in part by challenges that the Agency has faced and recommendations stemming from a 2007 report by the FDA Subcommittee on Science and Technology[1] that followed closely upon the Institute of Medicine’s report on the Future of Drug Safety.[2] One consequence of this report was a joint undertaking by the FDA, the Defense Advanced Research Projects Agency and the National Institutes of Health that was launched in 2010 to promote research in the field of regulatory science.[3]

The overarching goal of this collaborative Regulatory Science Initiative is to foster the development, evaluation and availability of new or improved tools, methods, standards, and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.[4]  Even more recently still, a variety of enhancements included in the Prescription Drug User Fee Act V (2013-2017) legislation make it clear that regulatory science remains a priority of the Agency leadership and staff.[5]

[1] FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology.  Prepared for FD Science Board. November 2007.  Available at: http://www.iom.edu/~/media/Files/Activity%20Files/PublicHealth/MedPrep/2010-FEB-22/Feb-24-Session-5-Cassell-FDA-Science.pdf  (Accessed July 1, 2013).
[2] Institute of Medicine. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press; 2006 Sep.
[3] Regulatory Science Program Snapshot.  Division of Program Coordination, Planning and Strategic Initiatives.  Available at: http://commonfund.nih.gov/regulatoryscience/   (Acccessed June 25, 2013).
[4] Hamburg MA. Advancing regulatory science. Science. 2011;331:987.
[5] Food and Drug Administration Safety and Innovation Act of 2012.  Available at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm  (Accessed July 1, 2013).