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FDA Denies Remaining Sunscreen TEAs, Offers Primer On Why They Fail

This article was originally published in The Rose Sheet

Executive Summary

In proposed orders to be published Feb. 25, FDA rejects L'Oreal USA’s time and extent application for ecamsule and Merck & Co.’s TEA for enzacamene. Division of Nonprescription Clinical Evaluation Director Theresa Michele acknowledges the decisions “may be disappointing to some.”

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