Withdrawal of Guidances on Estrogen and Estrogen/Progestin-Containing Drug Products

Riepilogo

The Food and Drug Administration (FDA) is announcing the withdrawal of two guidances: A draft entitled"Labeling Guidance for Noncontraceptive Estrogen Drug Products--Prescibing Information for Healthcare Providers and Patient Labeling" and a final "Guidance for Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women." These guidances are under agency review for change.