ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS
October 18, 1999
Briefing Information
September 27, 1999 letter to Members
Attachment 1: Draft Guidance for Industry, Establishing Pregnancy Registries
Attachment 2: Draft Guidance, Evaluation of Human Pregnancy Outcome Data
Attachment 3a: Draft Guidance of Industry, Labeling Guidance for Non-Contraceptive Estrogen Drug Products--Prescribing Information for Health Care Providers, and Patient Labeling
Attachment 3b: **Please note, we have included as reference, the current FDA guidance, Labeling Guidance for Estrogen Drug Products, Physician Labeling (dated August 1992). This guidance will be superceded upon finalization of the above draft guidance
Attachment 4: Guidance for Clinical Evaluation of Combination Estrogen/Progestin--Containing Drug Products used for Hormone Replacement Therapy of Postmenopausal Women