Tag: electronic health record

electronic health record

Regulatory/FDA

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Comment Now on FDA Draft Guidance on Use of EHR, Claims Data as RWD

Oct. 4, 2021 – As part of its real-world evidence (RWE) program, the Food and Drug Administration last week issued a draft guidance to provide sponsors, researchers and other stakeholders with the agency’s current thinking about the use of electronic health records (EHRs) or medical claims data in clinical studies “to support a regulatory decision […]

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