Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI)

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ABSTRACT The U.S. Food and Drug Administration's Centers of Excellence in Regulatory Science and Innovation provide institutions with a valued opportunity to work directly with regulators while simultaneously providing the FDA opportunities for access and exposure to advanced scientific exchange and training focused on the FDA's priority areas. As one of the world's leading institutions in higher education, Johns Hopkins University is pleased to collaborate with the FDA in the development of fundamental new knowledge and tools to advance regulatory science. Our proposal builds upon a historic alliance between these two vital organizations, including decades of exchange and partnership in the pursuit of scientific advancement and state-of-the-art regulation. During the past year alone, our CERSI has engaged in nearly a dozen original scientific investigations, focusing upon vital areas of regulation ranging from the role of flavorants in noncombustible tobacco products (Center for Tobacco Products) to the use of patient preference methods to design upper limb prostheses (Center for Devices and Radiologic Health). The JH-CERSI's investigations, conducted in close partnership with FDA scientists with stewardship from the Office of Regulatory Science and Innovation, have advanced the Agency's mission by strengthening the science underpinning its regulatory activities. Furthermore, these scholarly activities have been conducted while leveraging a variety of additional governmental and non-profit funding sources, providing the FDA with opportunities to considerably accelerate and amplify the investments made in the CERSI. Our CERSI also continues to support the training and professional development of the next generation of leaders in regulation through courses, workshops, seminars, competitions and certificate, master and doctoral degree programs. In the currently proposed award, we present more than two dozen scientific investigations focused on: (1) high priority topic areas, including tobacco, reducing health care associated infections, and addressing opioid use, misuse and dependence; (2) developing and evaluating new methods to improve the quality and safety of FDA-regulated products; and (3) creating methods and tools to improve quality and efficiency of clinical and post-approval evaluation of regulated products. Together, Johns Hopkins University and the U.S. Food and Drug Administration can continue to ensure that regulatory science flourishes, and in so doing, that the FDA continues to fulfill its primary charge - to safeguard the health and well-being of the public through the application of scientifically sound regulatory activities.