FDA estrogen guidances withdrawn
Executive Summary
FDA withdrawing final clinical trial guidance on estrogen/progestin therapy: "Guidance for Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women," agency says in Sept. 10 Federal Register notice. FDA is also pulling the draft labeling guidance "Labeling Guidance for Noncontraceptive Estrogen Drug Products: Prescribing Information for Healthcare Providers and Patient Labeling." The decision comes after the NIH Women's Health Initiative trial was halted due to an increased risk of breast cancer and cardiovascular events in patients on Wyeth's Prempro (1"The Pink Sheet" July 15, p. 11). FDA plans to hold a public meeting on the hormone therapy issue this fall (2"The Pink Sheet" Aug. 19, p. 11)...