FDA Guidance News
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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