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A Tale Of Two Expectations: NDI Notification Estimate And Guidance

Regulatory Burden Notice Prompts Doubt While Hope Endures For Revised Draft

This article was originally published in The Tan Sheet

Executive Summary

FDA’s estimates for supplement manufacturers’ burden for submitting NDI notifications continue to miss the mark widely, say trade group executives. The agency would be more on target, they say, with a revised draft guidance on NDI notifications expected to reflect stakeholders’ suggestions.

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