Draft Guidance for Industry on Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-Recommendations for Clinical Evaluation; Availability

Résumé

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommendations for Clinical Evaluation." The agency is revising its guidance for industry entitled "Guidance for Clinical Evaluation of Combination Estrogen/Progestin- Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women," which was issued in March 1995 (the 1995 guidance). Once finalized, this guidance will replace the 1995 guidance.