FDA issues new framework to advance use of real-world data

December 7, 2018

The Food and Drug Administration is expanding its use of real-world data—such as electronic health records, medical claims and registries—to improve regulatory decisions regarding drugs and biologics.

“Because they include data covering the experience of physicians and patients with the actual use of new treatments in practice—and not just in research studies—the collective evaluation of these data sources has the potential to inform clinical decision making by patients and providers, develop new hypotheses for further testing of new products to drive continued innovation and inform us about the performance of medical products,” said FDA Commissioner Scott Gottlieb, MD, in a written statement.

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