Sunscreen Ingredient TEA Decisions Highlight Challenges Of NDA Scale

This article was originally published in The Rose Sheet

07 Jul 2014
News

Malcolm Spicer @TheTanSheet malcolm.spicer@informa.com

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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Sunscreen Ingredient TEA Decisions Highlight Challenges Of NDA Scale

News

Executive Summary

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