FDA Proposes Illuminating OTC Monograph Process With Sunscreen TEA Framework

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.

FDA's proposal to use timelines similar to its framework for sunscreen ingredient time and extent application reviews for evaluations of other drug ingredients proposed for OTC monographs points out that the agency is not changing its standards for approving monograph changes.

While setting deadlines for multiple steps in its reviews of TEAs for OTC ingredients should make the monograph process more transparent to the drug industry, establishing timelines for sunscreen ingredient...

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