Associate Director for Guidance & Scientific Policy, Office of Clinical Pharmacology
US Food & Drug Administration
Rajanikanth (Raj) Madabushi has over 15 years of regulatory experience. As a Pharmacometrics Reviewer and Clinical Pharmacology Team Lead, Dr. Madabushi has played a key role in the advancement and application of MIDD approaches for regulatory decision making and addressing various drug development issues. He currently serves as the Associate Director, Guidance and Scientific Policy in the Immediate Office of Office of Clinical Pharmacology. Dr. Madabushi plays an instrumental role in FDA’s PDUFA VI MIDD initative and is the CDER Point-of-Contact for the MIDD Paired Meeting Pilot Program. Dr. Madabushi is also involved in global harmonization activities as the Rapporteur for ICH M12 Expert Working Group – Drug Interaction Studies. Dr. Madabushi received his PhD. in Pharmaceutical Sciences from Birla Institute of Technology and Sciences (BITS), Pilani, India.