Sarah Pope Miksinski, PhD FDA

Sarah Pope Miksinski, PhD, is the Acting Director of the FDA's Office of New Drug Products (ONDP), in the Office of Pharmaceutical Quality (OPQ). 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 (2000-2002). Sarah joined FDA nearly 13 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 and Division Director. Sarah's areas of technical expertise include the characterization of complex drug substances/products, manufacture of injectable dosage forms, and spectroscopic methodology. During her years at FDA, she has been active in numerous quality initiatives including the integration of review/inspection, the development of the team review process, the Pharmaceutical Inspectorate, and the establishment of enhanced collaborative approaches to facilitate the review of urgently needed drugs.