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Home » FDA Issues Guidances on Real-World Data/Evidence Submission and Labeling Issues
FDA Issues Guidances on Real-World Data/Evidence Submission and Labeling Issues
In just six pages of final guidance released today, the FDA lays out exactly when and how sponsors should include real-world data and real-world evidence (RWD/RWE) in applications for investigational and new drugs, as well as biologics licenses.