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NDAC Input Sought On Sunscreen Ingredient Data Necessary For Approval

This article was originally published in The Rose Sheet

Executive Summary

FDA’s Nonprescription Drugs Advisory Committee will meet Sept. 4-5 to discuss the scope of safety testing necessary for OTC sunscreen ingredients, following FDA’s rejection this year of three time-and-extent applications to add new sunscreen actives to the OTC monograph. The committee’s input will be valuable if FDA faces deadlines for sunscreen TEA decisions under the Sunscreen Innovation Act, which passed the House July 29.

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