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

First publishedMay 8, 13:34 UTC

Last updatedJul 12, 12:32 UTC · 13m ago

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The report

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.

Read the full report at FDA ↗

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organizationBiologics. The U.S. Food organizationDrug Administration organizationDrugs organizationFDA Issues Guidance organizationImprove Collection organizationPostapproval Pregnancy Safety Studies organizationPregnancy Safety Data

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FDA10