Project Summary We propose a 5-year renewal of the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), a consortia of the two leading sister campuses within the University System of Maryland (USM), and the Food and Drug Administration (FDA). M-CERSI leverages the biomedical and health outcomes strengths in Baltimore with the engineering and technologies strengths in College Park. Aims include: Establish core program infrastructure and work plan to ensure success; Conduct cutting-edge regulatory science research; Provide mechanisms to expand M-CERSI activities; Provide regulatory science information sharing opportunities; and Increase access to M-CERSI opportunities to faculty, FDA scientists, and trainees who are underrepresented in regulatory science. Proposed research projects align with FDA's regulatory science framework to modernize development and evaluation of FDA-regulated products, strengthen post-market surveillance and labeling of FDA-regulated products, and invigorate public health preparedness and response of the FDA, patients and consumers. All M-CERSI research is collaborative with FDA scientists and employs a vast array of research capabilities at the University of Maryland. Research is accentuated by a Research Scientist Collaboration Program and a robust program of information sharing opportunities, which includes workshops, scholars program, lectures, and the America's Got Regulatory Science Talent Competition. The sum of these activities describes a vibrant, cutting edge Center that stimulates innovative thought, disseminates understanding of regulatory sciences and practices, and generates new knowledge in support of the FDA's fundamental mission – to promote and protect the public health.