Sarah C. Pope Miksinski, PhD

Senior Director, Global Regulatory Excellence
Sarah Pope Miksinski, Ph.D., is the Acting Division Director for the Division of New Drug Quality Assessment 2 in the FDA's Office of New Drug Quality Assessment (ONDQA). She obtained her B.A. from Earlham College (1994), her doctorate in Organic Chemistry from Oklahoma State University (1999), and completed a postdoctoral fellowship from NIH (NIDA, 2000-2002). Sarah joined FDA approximately 12 years ago, serving initially as a Chemistry Reviewer for reproductive/urologic drugs. Since that time, she has held additional positions within ONDQA including Chemistry, Manufacturing and Controls Lead as well as Branch Chief. Sarah's areas of technical expertise include the characterization of complex drug substances/products, manufacture of injectable dosage forms, and spectroscopic methodology.