Sunscreen Ingredient TEA Decisions Highlight Challenges Of NDA Scale
This article was originally published in The Rose Sheet
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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FDA advises BASF that the information the firm submitted is not sufficient to establish octyl triazone as GRASE. The agency’s third rejection this year of a sunscreen time-and-extent application could raise concerns among lawmakers and industry members amid a push to move sunscreen ingredients through the TEA process so consumers have access to updated options for sun protection.
“Moving away from the monograph system when we are so close to the end” would “risk setting back the OTC drug review many years or even decades,” CHPA head Scott Melville says at an FDA public hearing. Other stakeholder s explain how the monograph system has failed industry and consumers.