Executive Summary

FDA's draft guidance on gingivitis products "attempt[s] to establish certain standards for the design and evaluation of studies that go further than scientifically and clinically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 Oct. 27 comments to the agency. The 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, J&J suggests specifying blinded trial requirements and revising the phrasing of inclusion/exclusion criteria. The Consumer Healthcare Products Association also submitted comments in October (1"The Tan Sheet" Nov. 7, 2005, p. 10)...