CTFA/CHPA request
This article was originally published in The Rose Sheet
Executive Summary
Consumer Healthcare Products Association and Cosmetic, Toiletry and Fragrance Association seek 60-day extension of comment period on FDA gingivitis drug products draft guidance from Aug. 29 to Oct. 28 to allow time "to coordinate an industry response and to provide the agency with meaningful and substantive comments," associations state in July 15 letter. FDA published a draft guidance June 28 focusing on clinical trial design issues for Rx and OTC gingivitis treatments (1"The Rose Sheet" July 4, 2005, In Brief)...