Public Comment
Comments provided on: September 18, 2025
Comments provided to: U.S. Food and Drug Administration; FDA-2025-D-1797
Description: The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) submitted public comments on the draft ICH E21 guidance regarding the inclusion of pregnant and breastfeeding women in clinical trials. The MRCT Center strongly supports the ethical inclusion of these historically understudied populations and emphasized the need for ethical and rigorous, well-designed research guided by participant and individual protections.