FDA Guidance Offers Suggestions on How to Leverage Real-World Data

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A new guidance from the U.S. Food and Drug Administration (FDA) is intended to help sponsors and other stakeholders designing a registry or using an existing registry with real-world evidence (RWE) and/or real-world data (RWD) to support regulatory decision-making about a drug’s effectiveness or safety.

FDA defines RWD as “data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources.”

FDA says RWE is “the clinical evidence about the usage and the potential benefits or risks of a medical product derived from analysis of RWD.”

In the guidance, FDA offers its perspectives on:

  • Considerations regarding a registry’s fitness-for-use in regulatory decision-making, focusing on attributes of a registry that support the collection of relevant and reliable data.
  • Considerations when linking a registry to another data source for supplemental information, such as data from medical claims, electronic health records, digital health technologies, or other registries.
  • Considerations for supporting FDA review of submissions that include registry data.

Edited by Michael Causey