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GUIDANCE DOCUMENT

Labeling for Combined Hormonal Contraceptives Guidance for Industry January 2018

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-1846
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 Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2017-D-1846.

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