Prevalence of Selected Health Conditions among Individuals with Childbearing Potential to Inform the Development of the Pregnancy Safety Study Framework

As part of the FDA User Fee Reauthorization Act of 2022, FDA has been developing the pregnancy safety study framework to address gaps in knowledge about the appropriate use of different study types. The framework can leverage the predicted magnitude of product exposure during pregnancy and study goal (signal identification or evaluation) to help identify the most appropriate study type to assess safety.

This poster estimates the prevalence of key conditions in individuals with child-bearing potential (ICBP) to generate an informed estimation of potential product magnitude of exposure during pregnancy upon approval. It was presented at the 2024 ISPE Annual Meeting.