Speakers

Yafei Jin is currently a drug product quality assessor in the Division of Liquid-Based Products II, at the Office of Lifecycle Drug Products (OLDP) within the Food and Drug Administration (FDA). In her current role, Yafei is responsible for assessing drug product quality of abbreviated new drug applications (ANDAs), responding to controlled correspondences, pre-ANDA meeting requests, and internal consults. Yafei received her Master of Science degree in Medicinal Chemistry from the University of Michigan in Ann Arbor. Prior to her tenure at FDA, she has worked as a chemist across various domains, including the pharmaceutical industry (Cumbre Pharmaceutics), academia (University of Michigan), and government service (Walter Reed Army Institute of Research), with many years of diverse experience in drug product development, chemical synthesis, and evaluation. She has been with the FDA since 2017, conducting generic drug product quality assessments, with a focus on the complex liquid drug products.