Drug Safety in Pregnancy: Methods and Challenges

16 Pages

This white paper reviews approaches used to evaluate medication safety during pregnancy, highlighting regulatory expectations and real-world data limitations. It compares methods such as pregnancy registries, surveillance programs, database studies, and utilization analyses, while addressing challenges like exposure timing, confounding, and outcome measurement. The paper outlines future directions to strengthen evidence generation and support informed decision-making.

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Drug Safety in Pregnancy: Methods and Challenges

Drug Safety in Pregnancy: Methods and Challenges

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