Leveraging RWD to improve regulatory decisions

  • How real world evidence was used to support approval of Ibrance for male breast cancer
  • “Leveraging RWD to improve regulatory decisions is a key strategic priority for the FDA. This data may be derived from a variety of sources, such as electronic health records, medical claims, product and disease registries, laboratory test results and even cutting-edge technology paired with mobile devices.

    These types of data are being used to develop real world evidence (RWE) that can better inform regulatory decisions.

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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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