FDA’s Regulatory Considerations for Electronic Health Records as Real-world Data

As an important part of real-world data, electronic health record is widely used in safety research and gradually used in effectiveness research. This article systematically introduces the FDA's considerations when researchers use electronic health record as real-world data to support drug regulatory decision-making in clinical research, with a view to providing reference for the application of electronic health record as real-world data in drug development and registration in China.