Jingyue Yang

Office of Testing and Research/OPQ/CDER, US FDA

Jingyue (Jan) Yang is a Sr. Research Scientist in the Division of Pharmaceutical Analysis in the Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ) at the FDA’s Center for Drug Evaluation and Research (CDER). In her various roles, Jan develops and applies analytical methods to assess the quality of pharmaceutical products and to investigate adverse events associated with medical product use. She also performs research to improve the characterization and understanding of complex drug substances and products to support generic drug assessment and approval. Jan has been a key team member to provide analytical support to the FDA’s task force for the investigation of nitrosamine contamination in the past few years. She has developed important analytical methods to detect and quantitate various nitrosamines in pharmaceutical products and is currently conducting research to study the prevalence of nitrosamine contamination in pharmaceuticals and to investigate risk mitigation strategies. Jan earned her B.Sc. in chemistry from Beijing University in China and received her PhD in chemistry from Washington University, Saint Louis, MO. She was a postdoctoral researcher in biomedical research and worked as an analytical chemist at a pharmaceutical company prior to joining FDA in 2014.