This guidance updates the final guidance Guidance for Clinical Evaluation of Combination Estrogen/Progestin - Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women, published in March 1995. The guidance is intended to provide recommendations to industry for studies of estrogen and estrogen/progestin drug products for the treatment of moderate to severe vasomotor symptoms associated with the menopause and moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. The guidance also addresses the reduction of the risk of endometrial hyperplasia or adenocarcinoma from estrogen exposure in postmenopausal women who have a uterus. For other indications, such as prevention of osteoporosis, sponsors are asked to direct inquiries to the appropriate CDER Office of New Drugs review division.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.