FDA Wants Better Pregnancy Safety Data on Approved Drugs

FDA Wants Better Pregnancy Safety Data on Approved Drugs

(MedPage Today) -- The FDA on Friday issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics in pregnancy, with the goal of better understanding potential risks for the pregnant patient and...

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

White Oak, Md., May 08, 2026 (GLOBE NEWSWIRE) -- 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…