Speakers

Utpal M. Munshi, Ph.D., is the Division Director (Acting) of the Division of Bioequivalence I (DBI) in the Office of Bioequivalence, Office of Generic Drugs, CDER, FDA. He leads a team of scientists responsible for the assessment of the bioequivalence section of Abbreviated New Drug Applications and other stakeholder submissions. During his time in DBI, Dr. Munshi has had a variety of technical and administrative roles and has participated in the drafting of numerous Agency guidances pertaining to bioequivalence. Dr. Munshi received his Ph.D. in Biological Chemistry from the University of Michigan and then undertook post-doctoral training at the National Cancer Institute in Frederick Maryland before joining DBI in 2007.