Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
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- Title
- Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
- Posted
- Jul 25, 2024
- Comment period
- Jul 25, 2024 – ?
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- Jun 9, 2026Comment from AISHA HASSAN-DAVISSupportIndividual
A healthcare provider supports the FDA's guidance on using real-world data from electronic health records and medical claims to inform regulatory decisions. They argue that these data sources provide valuable insights into medication performance in routine practice and can improve patient safety and access to treatments, particularly for underrepresented populations.
Read comment → - Jun 9, 2026Comment from AISHA HASSAN-DAVISSupportIndividual
A healthcare provider supports the FDA's guidance on using real-world data from electronic health records and medical claims to inform regulatory decisions. They argue that these data sources provide valuable insights into medication performance in routine practice and can improve patient safety and access to treatments, particularly for underrepresented populations.
Read comment →