FDA Guidance News

| Stat One






To manage tracking of submissions that include real-world data (RWD) and real-world evidence (RWE), the FDA has released a final guidance asking for identification of such data. This applies to INDs, NDAs, and BLAs that contain RWD/RWE intended to support a regulatory decision regarding safety and effectiveness.

The FDA defines RWD as data relating to patient health status and the delivery of health care that are routinely collected from a variety of sources.

Examples include:

  • Electronic health record (EHR) data
  • Medical claims data
  • Product or disease registry data
  • Data obtained from digital health technologies
  • Data gathered from other sources that can inform on health status, such as questionnaires

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


See full final guidance by clicking here.


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