Issue Date: July 21, 2025
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Efficacy
Status: Draft
E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for Industry
Office of the Commissioner, Office of Women's Health The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding women in clinical trials and facilitate the generation of robust clinical data that allow for evidence-based decision making on the safe and effective use of medicinal products by these women and their healthcare providers (HCPs).
Download the Guidance Document
