Policy Lead
US Food and Drug Administration
Anuradha Ramamoorthy, Ph.D., is a Policy Lead in the Guidance and Policy Team (GPT) in the Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). In her current role, Dr. Ramamoorthy contributes to regulatory policy development, stakeholder engagement, and research focused on clinical pharmacology. Prior to that she was a Reviewer in OCP contributing to the regulatory review of investigational new drug (IND), new drug application (NDA), and biologic licensing application (BLA) to effectively incorporate pharmacogenomic and clinical pharmacology strategies in drug development. She is co-investigator in a number of research projects that are focused on current and emerging regulatory topics that impact the development, evaluation, and utilization of new drugs. Dr. Ramamoorthy received her Ph.D. in Medical and Molecular Genetics from Indiana University and completed her post-doctoral fellowship at the National Institute on Aging (NIA, NIH) and at OCP, FDA. Dr. Ramamoorthy has been a member of ASCPT since 2007 and has served in the scientific programming committee, education and career development committees, strategic planning task force, and community and network leadership.