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# Confusion Exists in RWD/RWE Definitions: Analysis
- URL: https://www.fdaweb.com/confusion-exists-in-rwd-rwe-definitions-analysis/
- Published: 2023-10-19T12:00:00.000Z
- Updated: 2026-09-14T14:13:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155610

Nine staff members in various positions in FDA, CDER, and CBER say the terms real-world data (RWD) and real-world evidence (RWE) are often used interchangeably and inconsistently, including in submissions to the agency involving RWE to evaluate the effectiveness of drugs and biologic products. Writing in an open-access [commentary](ttps://onlinelibrary.wiley.com/doi/10.1002/pds.5715) in *Pharmacoepidemiology & Drug Safety*, the authors say that although a misconception sometimes exists that only non-interventional studies use RWD to generate RWE, the spectrum of study designs involves various combinations of data sources and design architecture that determine whether RWE is generated.

“Attempts by various stakeholders to identify the role of RWE in regulatory decision-making often do not focus on the contribution of RWD in specifically evaluating drug-drug interactions,” the article says.

The writers trace the FDA’s use of RWD and RWE and discuss two agency approvals that illustrate how RWD can be used to generate RWE as part of a marketing application for regulatory decision-making.