In July 2025, the U.S. Food and Drug Administration (FDA) published the draft guidance “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials”. The draft guidance, developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations.