FDA Seeks Comments on Pregnant Women in Trials

FDA is reminding companies and the public that they have until 9/19 to submit comments on a draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. The document provides recommendations for the appropriate inclusion and retention of pregnant or breastfeeding women in clinical trials.

The agency says the scope of the guidance includes pre- and post-marketing clinical trials of investigational products for indications in the general population and indications specific to pregnant or breastfeeding women. “In principle, inclusion of pregnant and breastfeeding women in clinical trials should be considered for all products where women of childbearing potential are among the anticipated user population,” it says. “It is especially important for conditions where there is high unmet medical need for treatment in pregnancy or while breastfeeding; however, the scope of this guideline is not limited to these scenarios.”

Comments should be submitted to Docket No. FDA-2025-D-1797.