Gingivitis comments
This article was originally published in The Rose Sheet
Executive Summary
FDA draft guidance on gingivitis products "attempt[s] to establish certain standards for the design and evaluation of studies that go further than scientifically and clinically desirable and appropriate," Church & Dwight states in recent comments to the agency. Guidance was released in June by FDA to aid sponsors with developing Rx and OTC products to treat gingivitis. "When standards are set unnecessarily and inappropriately high, useful products whose benefits exceed their risk cannot come to market," C&D adds. In a separate submission, Johnson & Johnson suggests specifying blinded trial requirements and revising the phrasing of inclusion/exclusion criteria. The Cosmetic, Toiletry and Fragrance Association submitted comments jointly with Consumer Healthcare Products Association in October, recommending the draft document encourage the use of new indices that provide "meaningful and clinically relevant measures" of gingivitis (1"The Rose Sheet" Nov. 7, 2005, p. 8)...
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