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GUIDANCE DOCUMENT

Labeling for Combined Hormonal Contraceptives Guidance for Industry December 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.