E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials Draft Guidance for Industry July 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trials?utm_medium=email&utm_source=govdelivery Download the draft guidance document (PDF, 430KB) https://www.fda.gov/media/187755/download?utm_medium=email&utm_source=govdelivery