CDER’s Office of Pharmaceutical Quality’s Hongbio Liao and Office of Generic Drugs’ Victoria Keck discuss impurities. A top RTR is due to impurity issues. Liao and Keck cover FDA adequate and inadequate impurity submissions. They also troubleshoot impurity challenges to include Potential Genotoxic Impurity (PGI) assessment in Type II DMFs as well as safety justifications for impurities exceeding International Conference on Harmonisation (ICH) limits in ANDAs.

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