The University of Maryland's Center of Excellence in Regulatory Science and Innovation (CERSI) is funded by an initial $1 million grant from the U.S. Food and Drug Administration (FDA). In a new FDA effort, the center focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.
The center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland in Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Through the CERSI, researchers, regulators and industry professionals can learn from one other in the effort to develop regulatory science practices that promote innovation in medical devices and pharmaceuticals, while also addressing critical safety concerns.
This website highlights regulatory science activities at the center and coalesces center research projects into an information-rich resource base. The site will be populated with articles and opinion statements by CERSI researchers.