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Real-World Data: FDA Urged To Distinguish Between Electronic Health Records And Medical Claims

 
• By Sue Sutter

Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.

Yellow and red
Pharma and data companies want the FDA to better distinguish between electronic health records and claims data in a real-world data guidance. • Source: Alamy

The US Food and Drug Administration’s recent guidance on assessing electronic health records and claims databases to support regulatory decision-making should better distinguish between these two types of real-world data sources, stakeholders said.

Industry comments on the draft version of the guidance released in September also call for more specifics as to how pharmaceutical sponsors and data providers can meet with the agency...

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