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# FDA Draft Guide on Pregnant Women in Clinical Trials
- URL: https://www.fdaweb.com/fda-draft-guide-on-pregnant-women-in-clinical-trials/
- Published: 2018-04-09T12:00:00.000Z
- Updated: 2026-09-14T23:58:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141175

*Federal Register* notice: FDA has made available a draft guidance on “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” The document discusses ethical and scientific issues when considering the inclusion of pregnant women in clinical trials involving drugs and biological products. It is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-09/pdf/2018-07151.pdf?ref=fdaweb.com).