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FDA Proposes September Deadline For Sunscreen Rule...And May Stick To It

This article was originally published in The Rose Sheet

Executive Summary

Meeting proposed deadlines on regulatory agenda actions, such as finalizing OTC monographs, could be a higher priority for FDA under its new management

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FDA re-targets final sunscreen rule for May

According to Department of Health and Human Services' Dec. 7 semi-annual agenda, FDA aims to publish a final monograph for OTC sunscreen products in May. The agency has missed its target before, shooting for September in its summer 2009 agenda (1"The Rose Sheet" June 1, 2009). The final version of the monograph - which would address requirements for UVA protection - initially emerged in 1999 but has been consistently delayed. "FDA believes it is important to public health that we issue a final rule for OTC sunscreens as soon as possible," an FDA spokeswoman wrote in a March 17 e-mail to "The Rose Sheet." The agency is likely to take fire if another summer passes without formal protection standards for sunscreen manufacturers (2"The Rose Sheet" Nov. 24, 2008, In Brief)

FDA re-targets final sunscreen rule for May

According to Department of Health and Human Services' Dec. 7 semi-annual agenda, FDA aims to publish a final monograph for OTC sunscreen products in May. The agency has missed its target before, shooting for September in its summer 2009 agenda (1"The Rose Sheet" June 1, 2009). The final version of the monograph - which would address requirements for UVA protection - initially emerged in 1999 but has been consistently delayed. "FDA believes it is important to public health that we issue a final rule for OTC sunscreens as soon as possible," an FDA spokeswoman wrote in a March 17 e-mail to "The Rose Sheet." The agency is likely to take fire if another summer passes without formal protection standards for sunscreen manufacturers (2"The Rose Sheet" Nov. 24, 2008, In Brief)

FDA Nonprescription Office Expects Progress On Sunscreen Monograph

With added expertise in the FDA's Division of Nonprescription Regulation Development, the division aims to make headway on the long-delayed OTC sunscreen monograph

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