Real-World Evidence: US FDA Urged To Leverage Prior Validation Work and Regulatory Experience

In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do more to publicize the experience to date with RWE in regulatory submissions.

Wagon wheel
There is a desire not to have to reinvent the proverbial wheel each time a real-world data source is used. • Source: Alamy

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