Keduo Qian PhD U.S. FDA

Keduo Qian joined DLAPI/ONDP/FDA in 2013 as a drug master file (DMF) reviewer. Previously, she was Research Assistant Professor of Medicinal Chemistry and Natural Products at the University of North Carolina at Chapel Hill. She received her Ph.D. in Pharmaceutical Sciences from UNC-Chapel Hill. In addition to the assessment of chemistry, manufacturing process, controls and stability of drug substances associated with DMFs, Keduo specializes in the quality assessment of complex active pharmaceutical ingredients (APIs), such as low molecular weight heparins (LMWHs), polymers, peptides, etc. Keduo was on detail to the Office of Pharmaceutical Manufacturing Assessment (OPMA) during 2018-2019, with emphasis on the assessment of complex API manufacturing as well as compliance of manufacturing facilities.