Bloomberg Law
Dec. 10, 2018, 11:30 AM

FDA’s Real-World Evidence Framework Is Out. Now What?

Jeannie Baumann
Jeannie Baumann

Drug companies could rewrite their playbooks for demonstrating how well their medicines work under a new FDA blueprint on how it will accept analyses of routine health data.

The Food and Drug Administration released its framework Dec. 6 on how it plans to incorporate real-world evidence—data pulled from electronic health records, claims data, and even data collected from mobile apps like Apple Watches and Fitbits—into its regulation of drug effectiveness.

The framework signals a major step forward for the FDA as it moves away from relying exclusively on data collected from expensive, time-consuming randomized controlled trials. Using real-world data—any health ...

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