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Clinical Lactation Studies: Considerations for Study Design May 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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

This guidance provides recommendations for sponsors conducting clinical lactation studies. The Food and Drug Administration (FDA or Agency) has required lactation studies under section 505(o)(3) of the Food, Drug, and Cosmetic Act (FD&C Act) under some circumstances and is considering additional circumstances in which lactation studies may be required. In addition, sponsors in some circumstances may elect to conduct lactation studies absent a requirement or request from the Agency.

This guidance reflects FDA’s current recommendations regarding pre- or post-marketing lactation studies by drug sponsors. This guidance provides information to facilitate the conduct of lactation studies. Such studies can inform breastfeeding with drug use recommendations included in the Lactation subsection of labeling.

The recommendations in this guidance reflect discussions from the 2007 Pediatric Advisory Committee meeting and the 2016 Lactation Workshop, which considered how data from clinical lactation studies can inform the safety of a drug when used during lactation. This draft guidance replaces the draft guidance for industry Clinical Lactation Studies — Study Design, Data Analysis, and Recommendations for Labeling, which published in February 2005.

Submit Comments

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-2018-D-4525. .

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