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). She leads CDER’s International Program, representing FDA at the International Council on Harmonization (ICH) where she serves as Chair of the ICH Management Committee. She also serves as FDA CDER representative to the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the International Pharmaceutical Regulators Programme (IPRP). 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 Program 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 $1B in annual funding. Before joining CDER in 2007, Dr. Mullin was the FDA Assistant Commissioner for Planning.

Since joining the 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, US Presidential Rank Awards including for Distinguished Service in 2011 and for Meritorious Service in 2006.