NDAC
This article was originally published in The Tan Sheet
Executive Summary
Guidance document entitled "Class Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)" to be available from FDA "in the next several weeks" following a June 26 Federal Register notice announcing the topics of the July 28-29 meeting of NDAC. The guidance document also will be available on the Internet at www.fda.gov. The topics of the meeting include class labeling of vaginal yeast infection treatments (July 28) and performance expectations and final formulation testing requirements of OTC healthcare antiseptic drug products (July 29) ("The Tan Sheet" March 2, p. 5). The meeting will take place at the Holiday Inn in Bethesda, Md., beginning at 8:30 a.m. both days. The NDAC meeting scheduled to take place July 27 was canceled ("The Tan Sheet" June 8, In Brief)...