United States of America. The Food and Drug Administration has announced the availability of a draft guidance for industry entitled “Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)”. The guidance is intended to provide a general labelling format for all over-the-counter (OTC) drug product for the treatment of vaginal yeast infections and provides recommendations for both the carton and the educational brochure.
Copies of the draft guidance documents are available from the Drug Information Branch, (HFM-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville MD 20857, USA (with one self- addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.
Reference: Federal Register 63(136): 38412-3 (1998).