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Adverse-Event Data Requirement Among Sunscreen TEA Bugs – FDA

This article was originally published in The Rose Sheet

Executive Summary

The significant time and resources necessary to amend the monograph are one reason for FDA’s slow response to time and extent applications to add ingredients to the OTC sunscreen monograph, agency officials say. Another reason may be flawed data requirements in the application process, with the requirement for adverse-event reports cited as a particular challenge for both sponsors and the agency.

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