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avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

FDA
Associated Director for Guidance and Scientific Policy, 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. Currently he is the Associate Director for Guidance and Scientific Policy in the Immediate Office of the OCP. He is 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.