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Sunscreen Ingredient TEA Decisions Highlight Challenges Of NDA Scale

This article was originally published in The Rose Sheet

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Executive Summary

The TEA option has not provided a more efficient and economical method for drug industry stakeholders to convince FDA to expand OTC monographs with ingredients that have demonstrated safety records in foreign markets, but rather a system that rivals the rigors of the new drug application process. Former FDA attorneys offer perspective.

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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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