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Zdrowie i gospodarka · 4.03.2026

FDA Releases Final Guidance on Postapproval Safety Data Management

The FDA has released a final guidance on postapproval safety data management, clarifying the use of new data sources and terminology for adverse event reporting, replacing a draft guidance issued in 2024 and a 2003 final guidance.

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