Kristen Miller is a Health Scientist Policy Analyst in the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). She leads FDA’s activities with public private partnerships that reside under OMP. She joined the FDA in 2002, and prior to joining OMP, she was the special assistant to CDER’s Associate Director of Policy for all postmarketing safety activities under FDAAA and FDASIA, specifically Risk Evaluation and Mitigation Strategies (REMS), and was the Safety Regulatory Project Manager for the Office of New Drugs (OND) in CDER. She received her Pharm.D. from the University of Pittsburgh.