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Supplement NDI Draft Guidance Discussions Snagged On Basic Criteria

This article was originally published in The Tan Sheet

Executive Summary

FDA’s dietary supplement division is concerned that firms are not submitting NDI notifications in cases where they should be, while industry stakeholders assert the agency needs to clarify the criteria for determining which products should be the subject of notifications and what information is needed.

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In Brief
FDA Revision Of NDI Draft Guidance Starts With Grandfathered List

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