FDA Updates Guidance on Data Backing Potential New Drug Uses

Researchers using electronic health records to show that an FDA-approved drug can have a different use than it was intended for should make sure their data is both relevant and complete, the agency advised in a draft guidance released Wednesday.

The draft guidance aims to help researchers use “real-world data” to show the Food and Drug Administration that a proposed use is safe and effective. The data—which can come from sources like electronic health records or medical claims—can be used as “real-world evidence” about a drug’s risks and benefits. The guidance is also meant for researchers trying to “satisfy postapproval ...