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Antiplaque comment deadline

This article was originally published in The Tan Sheet

Executive Summary

Comments on advance notice of proposed rulemaking for OTC Antigingivitis/Antiplaque Drug Products will be accepted until Nov. 25, FDA says in Federal Register notice scheduled for appearance Aug. 25. Reply comment period has been extended to Feb. 23, 2004. CHPA, CTFA jointly requested the extension to review data on ingredients the agency has proposed classifying as Category III in a July 15 petition (1"The Tan Sheet" July 28, 2003, In Brief)...

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Antiplaque comments deadline

Extension of deadline for comments on OTC antigingivitis/antiplaque advance notice of proposed rulemaking requested by CHPA, CTFA in July 15 joint petition to FDA. An additional 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 (insufficient data), rather than Category I (safe and effective), the groups state. CHPA, CTFA also request 90-day delay of the reply comment period, arguing industry needs time to answer agency's call for statistical protocol and efficacy data on certain combination products before tentative final monograph is published. ANPR was released May 29 (1"The Tan Sheet" June 2, 2003, p. 3)...

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