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Rajanikanth Madabushi, PhD

Associate Director for Guidance and Scientific Policy * Director for CDER QMCoE
FDA

Rajanikanth (Raj) Madabushi, PhD, has over 15 years of regulatory experience as a Pharmacometrics Reviewer and Clinical Pharmacology Team
Lead in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS) at CDER/FDA. He currently serves as the Associate Director,
Guidance and Scientific Policy in OCP and the Director of the CDER Quantitative Medicine Center of Excellence. Dr. Madabushi plays an instrumental role in FDA’s PDUFA MIDD initiatives and is the CDER Point-ofContact for the MIDD Paired Meeting Program. Dr. Madabushi was 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.

Disclosure(s): No financial relationships to disclose

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