E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials
7/21/2025 – The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance aims to provide general principles for the conduct of clinical trials involving pregnant and breastfeeding women, informing evidence-based decisions on the safe and effective use of medicinal products in these populations. The draft guidance outlines approaches for generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and lactation. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while minimizing the burden and harm to these participants.
Read the draft guidance. Comment period ends 9/9/2025.