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Zdrowie i gospodarka · 04/03/2026

FDA Announces Final Guidance on Non-Interventional Studies Using Real-World Data for Medicines Safety Assessment

The FDA has released a final guidance on planning, designing, analyzing, and reporting non-interventional studies that utilize real-world data for safety assessment of medicines, prepared under the auspices of the International Council for Harmonisation.

Source: Federal Register — Food and Drug AdministrationOpen original release →