The US Food and Drug Administration (FDA) has updated it’s guidance on how real-world data (RWD) can be used to provide real-world evidence (RWE) for regulatory needs. It includes new examples of where RWD is collected, how the data is determined to be fit-for-purpose, and when it can be used to regulate certain diagnostic tests.
The draft guidance is an update to the agency’s 2017 final guidance on how sponsors can use RWD to provide RWE in premarket applications. While the original guidance only addresses situations where RWE can be used for Humanitarian Device Exemption, Premarket Approval Application (PMA), and De Novo submissions, the draft guidance also addresses determinations under the Clinical Laboratory Improvement Amendments (CLIA)…
