FDA's denial of the two remaining sunscreen time-and-extent applications, including one for an ingredient available OTC through a new drug application process, signals “nothing's going to get to market” anytime soon through monograph changes, says an advisor for an advocacy group.
FDA Denies Remaining Sunscreen TEAs, Offers Primer On GRASE, Resources
FDA denies sunscreen TEAS for L'Oreal and Merck & Co., citing data gaps, according to proposed orders. Proponents of launching additional ingredients say the decisions point to continued gridlock in changing FDA’s OTC sunscreen monograph.
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