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Benzocaine studies

This article was originally published in The Tan Sheet

Executive Summary

CHPA's Oral Discomfort Task Group requests FDA meeting by end of April to "facilitate development of a mutually agreeable approach to studying clinically the benefits and use patterns of benzocaine," trade association says in March 22 letter to agency. CHPA will provide FDA with a background document two weeks before meeting containing rationale for the proposed study designs, responses to agency concerns about protocol. CHPA request responds to FDA's Jan. 8 letter, in which agency questioned proposed protocol for testing efficacy of benzocaine and eugenol for toothache relief (1"The Tan Sheet" Jan. 21, 2002, p. 5). Eugenol-related issues "will be addressed separately," CHPA says...

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