This article was originally published in The Tan Sheet
The Consumer Healthcare Products Association requests 30 minutes to address the Nonprescription Drugs Advisory Committee during its meeting on Sept. 25. In its letter to FDA, CHPA attached rough guidelines as discussed at a February 2005 FDA roundtable regarding consumer behavior. CHPA said it has used the information from the roundtable and May 2005 Regulatory and Scientific Conference in "formulating our recommendations for refining the evaluation of studies to support marketing approval of OTC products." Former CHPA VP-Regulatory & Scientific Affairs Douglas Bierer will represent CHPA at the meeting. FDA announced the agenda of its NDAC meeting in Aug. 28 briefing documents (1"The Tan Sheet" Sept. 4, 2006, p. 3)...
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