Issue Date: January 2, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Draft
Labeling for Combined Hormonal Contraceptives Guidance for Industry
This guidance provides recommendations on information that should be included in the 19 prescribing information for combined hormonal contraceptives (CHCs) that contain estrogen and progestin. CHCs include combined oral contraceptives (COCs), as well as non-oral products such as transdermal systems and vaginal rings. Many of the labeling recommendations in this 22 guidance represent class labeling that should be included in all CHC prescribing information.
Download the Guidance Document
