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Expanded IND Guidance Threatens Supplement Research, Innovation

This article was originally published in The Tan Sheet

Executive Summary

Recent FDA guidance indicating that dietary supplement clinical studies with disease endpoints require an IND application could render the sale of some new dietary ingredients in foods unlawful, CRN argues. The expanded scope of FDA’s requirements for IND applications further stifles innovation by adding unnecessary regulatory barriers and costs, CHPA and others add in comments to the agency.

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