David J. Skanchy

David J. Skanchy is a senior supervisory regulatory review officer, 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 David J. Skanchy

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

ByJizhou Wang,Neeru Takiar,Huyi Zhang,David J. Skanchy

February 2nd 2017

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

Latest Updated Articles

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs
Published: February 2nd 2017 | Updated:

David J. Skanchy

Articles by David J. Skanchy

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

Latest Updated Articles

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