Theresa Mullin

Theresa Mullin is the CDER Associate Center Director for Strategic Initiatives. She oversees areas of strategic interest leading a variety of CDER efforts including Patient-Focused Drug Development (PFDD) and CDER’s International Program. She represents FDA at the International Council on Harmonization (ICH) Assembly and Management Committee and she serves as ICH Management Committee Vice-Chair. Dr. Mullin also serves on the Management Committee of the International Pharmaceutical Regulators Program (IPRP) and represents FDA in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) where she recently chaired the Sub-Committee on Budget and Audit Risk and served on the PIC/S Executive Bureau. Within the International Coalition of Medicines Regulatory Authorities (ICMRA) she co-chairs the Pharmaceutical Quality Knowledge Management (PQKM) Working Group advancing work on a global capability to enable regulatory reliance to advance the availability of critical medicines for patients, including collaborative assessment pilots addressing manufacturing post approval changes. Dr. Mullin previously served as director of CDER’s Office of Strategic Programs which she established and led for almost a decade. She led FDA negotiations with industry to support the 2017 reauthorization of the Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act and led the previous 3 cycles of negotiation for the 2002, 2007 and 2012 reauthorizations of PDUFA, now providing over $1B in annual funding for human drug review. Before joining CDER in 2007, she served as FDA Associate Commissioner for Planning. Since joining FDA Dr. Mullin has received numerous awards including the 2023 DIA Global Inspire Award for Global Connector, 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, the FDLI 2017 Distinguished Service and Leadership Award, and the US Presidential Rank Awards including for Distinguished Service in 2011 and for Meritorious Service in 2006. She earned a bachelor’s degree in economics, graduating magna cum laude from Boston College, and doctorate in public policy analysis from Carnegie-Mellon University.