Zdrowie i gospodarka · 27/09/1999

Draft Guidance for Industry on Noncontraceptive Estrogen Class Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling Guidance for Noncontraceptive Estrogen Drug Products--Prescribing Information for Healthcare Providers and Patient Labeling.'' The draft guidance is intended to serve as a template for sponsors of estrogen class drug products to ensure that such products contain uniform health care provider and patient labeling information. FDA published a notice of availability of an earlier version of this draft guidance in the Federal Register of October 15, 1998 (63 FR 55399). The agency received numerous comments. As a result, the original draft guidance was revised substantially and is being issued in draft for a second time.