Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support regulatory decisions for drugs and biologics

On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage information gathered from real-world data (RWD): data that relates to patient health status and/or the delivery of health care routinely collected from a variety of sources.

From RWD, FDA aims to gather RWE – which it defines as "clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD" – in order to inform regulatory decisions for drugs and biologics, such as supplemental approvals and labeling changes, and to satisfy post-marketing study requirements. Examples of RWD include patient-generated data as well as data derived from electronic health records (EHRs), medical claims and billing data, product and disease registries, and other sources that can inform on health status, such as mobile devices.

Read More: Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support regulatory decisions for drugs and biologics


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