Zdrowie i gospodarka · 15.10.1998

Draft Guidance for Industry on Non-Contraceptive Estrogen Class Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling Guidance for Non-Contraceptive Estrogen Drug Products--Physician and Patient Labeling.'' The draft guidance is intended to serve as a template for sponsors of estrogen class drug products to ensure that such products contain uniform physician and patient labeling information. Once finalized, this draft guidance will replace the ``Labeling Guidance for Estrogen Drug Products, Physician Labeling'' and ``Labeling Guidance for Estrogen Drug Products, Patient Package Insert,'' both of which were revised and published in August 1992.