Theresa Mullin PhD

Director, Office of Strategic Programs, FDA

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 Chair. Dr. Mullin also serves on the Management Committee of the International Pharmaceutical Regulators Programme (IPRP). She represents FDA in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) where she chairs the Sub-Committee on Budget and Audit Risk and is a member of 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 regulatory capability to enhance the availability of quality medicines to patients. 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 Assistant 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, US Food and Drug Law Institute 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 a doctorate in public policy analysis from Carnegie-Mellon University.

Appearances