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Drug Approval Standards Drug Safety FDA

FDA Busy Sorting OTC Monograph Ingredients Anticipating System Overhaul

This article was originally published in The Pink Sheet & The Rose Sheet

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Executive Summary

FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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