12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions.  

FDA defines real-world evidence (RWE) as the clinical evidence regarding a medical product’s use and potential benefits or risks that is derived from analysis of real-world data (RWD), which are data relating to patients’ health status and health care delivery.

Observational studies that use RWD to generate RWE could potentially contribute to regulatory decision-making about drug effectiveness, but there needs to be confidence in the validity of such evidence.

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