ICH Calls for Paradigm Shift in Enrolling Pregnant Lactating Women

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Draft ICH Guideline Calls for Paradigm Shift in Enrolling Pregnant and Lactating Women in Clinical Trials

J.W. Schomisch

June 13, 2025 at 03:18 PM EST

A draft International Council for Harmonisation (ICH) guideline recommends pregnant and breastfeeding women should be considered as clinical trial subjects “for all medicines intended for people who can potentially give birth to children.” The guideline “marks a change in paradigm in the development of medicines in pregnancy and breastfeeding,” the European Medicines Agency (... Read More

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Draft ICH Guideline Calls for Paradigm Shift in Enrolling Pregnant and Lactating Women in Clinical Trials

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