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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