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# Draft Guide on Pregnancy, Lactation Drug Labeling
- URL: https://www.fdaweb.com/draft-guide-on-pregnancy-lactation-drug-labeling/
- Published: 2020-07-30T12:00:00.000Z
- Updated: 2026-09-14T16:23:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147319

*Federal Register* notice: FDA has made available a draft guidance entitled “Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format.” The document provides clarification and additional information on recommendations to applicants submitting NDAs, BLAs, and efficacy supplements to approved NDAs or BLAs. To view the notice, click [here.](https://www.govinfo.gov/content/pkg/FR-2020-07-30/pdf/2020-16530.pdf?ref=fdaweb.com)