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avatar for Theresa Mullin

Theresa Mullin

FDA, United States
Associate Director for Strategic Initiatives, CDER
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations for 2017 reauthorization of the Prescription Drug User Fee Act and also led the 2002, 2007 and 2012 PDUFA reauthorization cycles providing $1B in annual funding.  She received the 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, US Food and Drug Law Institute 2017 Distinguished Service and Leadership Award, 2011 Presidential Rank Award for Distinguished Service, for Meritorious Service in 2006.