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# Draft Guide on Lactation Study Designs
- URL: https://www.fdaweb.com/draft-guide-on-lactation-study-designs/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144071

*Federal Register* notice: FDA has made available a draft guidance entitled “Clinical Lactation Studies: Considerations for Study Design.” The document provides the agency’s current recommendations to sponsors about such studies during drug development. The studies are intended to provide information and data for completing the lactation subsection in a drug’s labeling. This guidance replaces a draft guidance entitled “Clinical Lactation Studies — Study Design, Data Analysis, and Recommendations for Labeling” that was issued 2/2005\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-09/pdf/2019-09528.pdf?ref=fdaweb.com).