The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
Huyi Zhang
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Huyi Zhang is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.
Articles by Huyi Zhang
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Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAsPublished: February 2nd 2017 | Updated:
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