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

 
• By Sue Sutter

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

A certification process for validated real-world data sources and public disclosure of FDA assessments of real-world evidence in drug applications are urged by stakeholders in the most recent set of comments responding to the agency’s guidance on electronic medical records and health claims.

The comments suggest a common desire to leverage prior validation work and regulatory experience, rather than having to recreate the proverbial wheel each time a dataset is used in the...

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