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ICH Q11 Redo: Officials Weigh New Approaches for Evaluating Starting Materials

This article was originally published in The Gold Sheet

Executive Summary

The pharmaceutical industry and regulators are wrangling yet again over what constitutes a starting material. While some are anticipating that an upcoming ICH question-and-answer document will clarify this question, others are suggesting that now may be a good time to resurrect some concepts from an earlier FDA guidance on starting materials that has since been withdrawn.

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