PROJECT SUMMARY/ABSTRACT As the world’s leading regulatory authority, and the country’s largest research university, the U.S. Food and Drug Administration and Johns Hopkins University are ideally suited to broaden and deepen their highly productive partnership through the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI). This program, launched in 2014, has produced fundamental and applied new knowledge impacting a breadth of regulated products, ranging from COVID-19 therapeutics (Center for Drug Evaluation and Research) to eCigarettes (Center for Tobacco Products) to upper extremity prostheses (Center for Devices and Radiologic Health). The program has also undertaken vitally important inquiries relevant to many understudied groups, including pregnant women, racial and ethnic minorities, children and individuals with opioid use disorder. This knowledge has been used by the FDA to support rule-making, guidance-development, and the alignment of strategic priorities, helping to ensure that the FDA remains a global leader in advancing the technical and scientific foundations of product regulation. Since its inception, JH-CERSI has also leveraged the historically close relationship between the FDA and Johns Hopkins, and our renewal builds upon the substantial infrastructure developed together over the past eight years. JH-CERSI’s successes reflect many strengths including remarkable commitment from the FDA’s Office of the Chief Scientist and Office of Regulatory Science and Innovation, the University’s internationally renowned scholarship in regulatory science, an immense training platform, close geographic proximity to the FDA, and a nimble and organic operational approach. In this renewal, we propose to capitalize on these strengths and on the numerous structural improvements we have made since inception. We also propose three new programmatic elements to amplify impact. First, we will appoint an Associate Director of Artificial Intelligence and an Associate Director of Data Science and Informatics to expand the depth and breadth of our activities across faculty, programs, centers and schools, including the world- renowned Whiting School of Engineering and the Johns Hopkins Applied Physics Lab. Second, we will develop new training, including in Preparedness and Public Health Communications, to address the major threat that misinformation poses to the FDA’s regulatory success. We also propose new interchange with leading overseas regulators, thereby enhancing global regulatory science. Finally, we will institute an External Partnerships Initiative to serve as a force-multiplier by leveraging the remarkable scientific networks of Johns Hopkins faculty in service of the FDA’s mission. Together, through these efforts, Johns Hopkins and the FDA will continue to achieve remarkable gains that allow the FDA to maximize its effectiveness and impact through state-of-the-art regulation in the 21st Century.