U.S. Food and Drug Administration
Suman Dandamudi Ph.D. is a staff fellow in the Office of Generic Drugs, FDA. She earned a Ph.D. in Pharmaceutical Sciences from Northeastern University, Boston, MA. Her Ph.D. research involved formulation and development of magnetically labeled cationic liposomes for tumor vascular targeting. In 2008, Dr. Dandamudi joined FDA as assessor in Division of Bioequivalence, where her responsibilities include the bioequivalence assessment of ANDAs, INDs and other regulatory submissions. She has vast experience in the review of bioanalytical aspects of different dosage forms including complex products like topical creams, liposomal drugs. In addition, Dr. Dandamudi also mentors’ new assessors, trains and provides guidance on the procedures and policies for in vivo and in vitro bioequivalence study assessment. She is actively involved in various working groups and presented at various meetings and workshops.
Wednesday, November 6
10:00 AM – 10:30 AM