USA – FDA finalizes guidance on real-world evidence in drug approvals
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of real-world data (RWD) and real-world evidence (RWE) in supporting regulatory decisions for drugs and biologics, offering recommendations for data access and safety monitoring.
The FDA guidance can be found on its website.
More information on RIS.World.
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vroby (12 mars 2024). USA – FDA finalizes guidance on real-world evidence in drug approvals. ELSIBI. Consulté le 12 octobre 2026 à l’adresse https://doi.org/10.58079/w0a2
