CHPA meeting request
This article was originally published in The Rose Sheet
Executive Summary
Consumer Healthcare Products Association says meeting with FDA is planned in June to discuss the results of a pilot study on 20% benzocaine-containing oral care products. Trade group requested a meeting with the agency in a March 25 letter. Study was conducted after CHPA received a feedback letter from FDA in October 2002, responding to the association's proposed research program on benzocaine for temporary pain relief from toothache. Results address several key questions outlined by FDA, CHPA says, including "assessment of the subject's comprehension of the label directions for dosing, methodology to assess efficacy and the duration of treatment effect." CHPA also plans to discuss proposed protocol to evaluate 10% and 20% benzocaine and proposed OTC label...