articleNew England Journal of MedicineDec 7, 2016Closed access

Real-World Evidence — What Is It and What Can It Tell Us?

Center for Biologics Evaluation and Research · Center for Drug Evaluation and Research · +2 more institutions

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Abstract

The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.

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