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Where does FDA say what counts as real-world evidence for a drug?

The FDA guidance site lists Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.

Open the official source
Official sourceFDAwww.fda.gov
Checked on October 15, 2026

Next steps

  • Read the guidance on the FDA guidance site.

From the question: Where does FDA say what counts as real-world evidence for a drug?