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Theresa Mullin

Associate Director for Strategic Programs, CDER
Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads Patient-Focused Drug Development which includes implementation of the 21st Century Cures Act. She leads the CDER International program and heads the FDA delegation to ICH, IPRP and other venues. She led FDA negotiations for re-authorization of PDUFA III, IV, V, and VI and negotiations for authorization of BSUFA I and II which currently provide over $1 Billion in annual funding for FDA drug review. Awarded the 2019 Reagan-Udall Award for Leadership in Regulatory Science and 2017 FDLI Distinguished Service and Leadership Award. Received a BA magna cum laude from Boston College and PhD from Carnegie-Mellon University.