Draft Guidance for Industry on Labeling for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-Prescribing Information for Health Care Providers and Patient Labeling; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Labeling Guidance for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-- Prescribing Information for Health Care Providers and Patient Labeling." The draft guidance is intended to assist applicants in developing labeling for new drug applications for such drug products. This is the second draft of the guidance, which initially issued in September 1999.