Draft Guidance for Industry on Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-Recommended Prescribing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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing Information for Health Care Providers and Patient Labeling." The draft guidance is intended to assist applicants in developing labeling for new drug applications (NDAs) for such drug products. This is the fifth draft of the guidance, which FDA initially published for comment in October 1998.