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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About SVMPharma

SVMPharma is an innovative strategic consultancy, specialising in Real-World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online Real-World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions. Clinical trial programmes do not reflect real-world clinical practice and outcomes, RWE supplements and enhances clinical datasets. SVMPharma’s specialist teams focus on delivering the outcomes that matter to your brand.

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