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 This draft guidance replaces the draft guidance for industry Clinical Lactation Studies — Study Design, Data Analysis, and Recommendations for Labeling, which published in February 2005.