US Food and Drug Administration Guidance on Real World Evidence

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The U.S. Food and Drug Administration (FDA) has recognized the importance of Real-World Evidence (RWE) as a valuable source of information to inform regulatory decisions. RWE, derived from Real-World Data (RWD), encompasses information about a patient’s health status and the delivery of healthcare, obtained from various sources outside of traditional clinical trials. Here’s how the FDA views and uses RWE.