Shaping the Future of Drug Development and Regulatory Decision-making
Recorded On: 01/24/2024
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The 2024 MIDD Webinar Series, coordinated by Ana Ruiz and Sihem Bihorel, is a series of webinars focused on shaping the future of drug development and regulatory decision-making. Topics range from regulatory aspects from a European perspective to methods for dose selection in rare diseases.
Rajanikanth (Raj) Madabushi
Associate Director, Guidance and Scientific Policy in the Immediate Office of Office of Clinical Pharmacology
Food and Drug Administration
Rajanikanth (Raj) Madabushi has over 15 years of regulatory experience. 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 the FDA’s PDUFA MIDD initiative and is the CDER Point-of-Contact for the MIDD Paired Meeting 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 Ph.D. in Pharmaceutical Sciences from Birla Institute of Technology and Sciences (BITS), Pilani, India.
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