John Concato

Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator and research center director at Yale University & the Department of Veterans Affairs, he now develops, coordinates, and implements medical policy programs and strategic initiatives, with a focus on real-world evidence (RWE). These efforts include overseeing RWE guidance development and demonstration projects, as well as engaging external stakeholders and contributing to the review of RWE submissions, in support of the agency’s evaluation of RWE as mandated by the 21st Century Cures Act.