OR WAIT null SECS
FDA
Neeru Takiar 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.
February 02, 2017
Appendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.