Business · 21/07/2025Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance on Including Pregnant and Breastfeeding Women in Clinical Trials

Summary

The FDA has released a draft guidance for industry on including pregnant and breastfeeding women in clinical trials, aiming to inform evidence-based decisions on the safe and effective use of medicinal products by these populations.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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