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FDA Proposes Illuminating OTC Monograph Process With Sunscreen TEA Framework

This article was originally published in The Tan Sheet

Executive Summary

A proposed rule that sets deadlines for multiple steps in its reviews of TEAs for OTC ingredients should make the monograph process more transparent to the industry, but a timeline for sunscreen ingredient TEAs, as required by the Sunscreen Innovation Act, has not opened a door on application approvals.


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