Sarah Pope Miksinski, Ph.D., is the Acting Director of 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 a postdoctoral fellowship from NIH (2000-2002). Sarah joined FDA nearly 11 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 and CMC Branch Chief, as well as her current position. Sarah's areas of technical expertise include the characterization of complex drug substances/products, manufacture of injectable dosage forms, and advanced spectroscopic methodology. Most recently, she has been active in the development of enhanced collaborative approaches to facilitate the availability of urgently needed drugs in the U.S. market.