Real-World Data: US FDA Sets High Bar For Electronic Health Records, Claims In Applications
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and medical claims datasets are fit for purpose, and addressing potential limitations in advance, are key themes of new draft guidance.
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New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.
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Agency’s approach to assessing real-world evidence for effectiveness will be guided by three key principles: fitness for use of the underlying data, adequacy of the study design, and satisfactory monitoring and data collection.