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FDA guidance

This article was originally published in The Tan Sheet

Executive Summary

"NDAs: Impurities in Drug Substances" guidance recommends NDA applicants refer to the ICH guidance document "Q3A Impurities in New Drug Substances" for clarification on the "identification, qualification and reporting of impurities in drug substances that are not considered new drug substances." Although the ICH document applies to new drug substances produced by chemical syntheses, FDA says the procedures "should also be considered" for NDAs covering changes to already approved substances such as new dosage forms or proposed combinations of approved moieties. The guidance, published in the Feb. 25 Federal Register, does not apply to herbal products or ANDAs, the agency notes

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