NDAC Input Sought On Sunscreen Ingredient Data Necessary For Approval
This article was originally published in The Rose Sheet
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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Ahead of a Sept. 17 committee markup of the Senate’s Sunscreen Innovation Act, bill sponsors and stakeholders held a briefing on Capitol Hill to generate support for the legislation, which has already passed in the House. The bill, S. 2141, has 15 co-sponsors and is expected to advance through committee to the Senate floor.
FDA’s Nonprescription Drug Advisory Committee will consider proposed tests for evaluating the safety of sunscreen ingredients that sponsors want to add to the OTC monograph. The committee will not consider the safety or efficacy of specific ingredients pending review via TEAs.
FDA’s work on time-and-extent applications and monograph updates, unlike its work in evaluating NDAs for some OTC drugs and for Rx products, is not supported by user fees. The difference shows in the stalled process for approving new monograph ingredients, says the acting head of FDA’s OTC drugs office.