👩⚕️Draft Guidance on Pregnant and Breastfeeding Women in Clinical Trials
E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance outlines regulatory requirements affecting clinical trials involving pregnant and breastfeeding women, increasing compliance burdens for businesses. This reflects new industry standards for data generation and participant recruitment, crucial for pharmaceutical companies.