Rajanikanth Madabushi, PhD, MBA

Director for CDER Quantitative Medicine Center of Excellence; Associate Director for Guidance and Scientific Policy
FDA

Rajanikanth (Raj) Madabushi, PhD, MBA, 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-of-Contact 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 information not submitted.

Presentation(s):

• FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

  Tuesday, October 21, 2025
  1:45 PM - 3:15 PM MDT

• Use of Fit-for-Purpose Program to Support the Reusability of Novel Tools for New Drug Development

  Tuesday, October 21, 2025
  2:05 PM - 2:25 PM MDT

• Panel - FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

  Tuesday, October 21, 2025
  3:05 PM - 3:15 PM MDT