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...
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 (Also see "Eugenol Inclusion In Oral Pain Monograph Requires Actual Use Data – FDA" - Pink Sheet, 21 Jan, 2002.), p. 5). Eugenol-related issues "will be addressed separately," CHPA says.... |