New FDA guidance on clinical trial inclusion
August 28, 2025 3 min read Add topic to email alerts Receive an email when...
inclusion
FDA Announces Availability of ICH Draft Guidance on Inclusion of Pregnant and Breastfeeding Women in Clinical Trials
On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and...
the inclusion of pregnant and breastfeeding women in clinical trials
Pregnant and breastfeeding women have historically been excluded from medical research, resulting in substantial gaps in evidence on the safety...
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