Theresa M. Mullin PhD

Theresa M. Mullin directs strategic programs including business informatics for CDER. The Office of Strategic Programs plays a lead role in a number of CDER’s strategic initiatives and modernization efforts including development of benefit-risk and other decision support tools, the international program, data standardization, lean management, program analysis, informatics, and major user fee negotiations.

Dr. Mullin currently leads the CDER Patient Focused Drug Development Initiative and the FDA delegation to the International Conference on Harmonization. She is serving as FDA lead negotiator for the upcoming Prescription Drug User Fee Act (PDUFA) reauthorization, having similarly led negotiations for 2012 PDUFA V and BSUFA authorizations. PDUFA currently generates nearly $800 million in fee revenues to support the process of human drug review.