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avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

FDA
Team Leader, Guidance and Policy Team, OCP, OTS, CDER
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing various drug development issues in the areas of Cardio-Renal, Hematology and Endocrinology drug products.In 2016, he became the Team Lead for the new formed Guidance and Policy Team in the Immediate Office of the OCP. Since then, he has been involved in the drug development, regulation, research and policy from a clinical pharmacology perspective. He is also the CDER Point-of-Contact for the PDUFA VI MIDD Pilot Meeting Program.