01.002 RWE GS May 2022 I 01-06-2022

FDA differentiates between real-world data (RWD) vs real-world evidence (RWE)

  • 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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