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Zdrowie i gospodarka · 22/12/2023

FDA Releases Final Guidance on Using Real-World Data to Support Drug Regulatory Decisions

The US Food and Drug Administration (FDA) has released a final guidance document outlining considerations for using real-world data to support regulatory decisions on drug effectiveness and safety, as part of its Real-World Evidence (RWE) Program.

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