FDA differentiates between real-world data (RWD) vs real-world evidence (RWE)
25 March 2022
- In developing its RWE program, FDA believes it is helpful to distinguish between the sources of RWD and the evidence derived from that data
- Evaluating RWE in the context of regulatory decision-making depends not only on the evaluation of the methodologies used to generate the evidence but also on the reliability and relevance of the underlying RWD
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Ref: RWEMAR2022VNA