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Real-World Data: US FDA Sets High Bar For Electronic Health Records, Claims In Applications

 
• By Sue Sutter

Demonstrating that electronic health record and medical claims datasets are fit for purpose, and addressing potential limitations in advance, are key themes of new draft guidance.

High bar
US FDA has set high expectations for sponsors seeking to use real-world data in product application submissions. • Source: Alamy

A new draft guidance from the US Food and Drug Administration sets a high bar for sponsors to establish that electronic health records and medical claims data are fit for purpose in demonstrating the effectiveness or safety of drugs and biologics.

The guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making For Drug and Biological Products,” provides recommendations on selecting data sources to maximize...

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