GUIDANCE FOR CLINICAL-EVALUATION OF COMBINATION ESTROGEN PROGESTIN-CONTAINING DRUG PRODUCTS USED FOR HORMONE REPLACEMENT THERAPY OF POSTMENOPAUSAL WOMEN/

The following guidance was prepared by the staff of the FDA's Division of Metabolism and Endocrine Drug Products to advise drug manufacturer s of current standards for the development of combined estrogen/proges tin drugs for the treatment of postmenopausal women. As stated in the footnote, ''(t)hese recommendations are based on current data and may require modification as additional data become available.'' The Divisi on is pleased that the editors of Menopause are willing to publish thi s guidance in a journal devoted to this subject and hope that the publ ication will generate a productive discussion of the various issues in volved.