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CTFA oral health care petition

This article was originally published in The Rose Sheet

Executive Summary

Comment extension for OTC antigingivitis/antiplaque drug products proposed monograph requested by the Cosmetic, Toiletry & Fragrance Association and the Consumer Healthcare Products Association in July 15 petition to FDA. Delaying due date for comments by 90 days to Nov. 25, instead of Aug. 25, would allow industry to prepare material addressing FDA's decision to classify several active ingredients as Category III, rather than Category I, the groups state. CTFA, CHPA also request 90-day delay of the reply comment period. Associations argue industry needs time to reply to agency's call for statistical protocol and efficacy data on certain combination products before tentative final monograph is published. Notice of proposed rulemaking was published May 29 (1"The Rose Sheet" June 2, 2003, p. 3)...
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