Draft Guidance for Industry on Combined Oral Contraceptives-Labeling for Healthcare Providers and Patients; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Combined Oral Contraceptives--Labeling for Healthcare Providers and Patients." FDA's Center for Drug Evaluation and Research is issuing this draft guidance for drug products in the combined oral contraceptives class. When finalized, the guidance should result in uniform labeling among combined oral contraceptive products. Uniform labeling is important to physicians and patients when they read and try to understand efficacy claims and safety risks associated with drug products in this class. In addition, this draft guidance is intended to provide sponsors of new combined oral contraceptive drug products with a labeling template.