Association for Accessible Medicines
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Dr. Keduo Qian is a senior chemist working in the Office of Product Quality Assessment III (OPQAIII), Office of Pharmaceutical Quality (OPQ), Center of Drug Evaluation and Research (CDER) at FDA. She is a member in the Product Specific Guidance Working Group, dedicated in creating a pathway for efficient development of product specific guidances for complex generics. She serves as the subject matter expert (SME) in the area of complex APIs, including oligonucleotides, polymers, botanical and complex mixtures, etc. She specializes in the CMC regulation of low molecular weight heparins (LMWHs), iron colloid products, polysaccharides such as pentosan polysulfate sodium, polymers, peptides, etc. She is also experienced in the assessment of complex API manufacturing and compliance of manufacturing facilities. She received her Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill.