Healthcare 1 min read

FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics

May 09, 2026

The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.

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Source: FDA Press Releases — US Government, Public Domain