United States of America. The Food and Drug Administration has announced the availability of a draft guidance for industry entitled “Labeling Guidance for Non-Contraceptive Estrogen Drug Products: Physician and Patient Labeling”, which is intended to serve as a template for sponsors of estrogen class drug products to ensure that such products contain uniform physician and patient labelling information. The draft guidance includes black box warning explaining the increased risk of cancer of the uterus associated with the use of estrogens.
Copies of the draft guidance documents are available from the Drug Information Branch, (HFM-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville MD 20857, USA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(199): 55399-55400 (1998).