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# FDA Acceptance of Real-World Data for Drug Approval
- URL: https://www.fdaweb.com/fda-acceptance-of-real-world-data-for-drug-approval/
- Published: 2020-06-09T12:00:00.000Z
- Updated: 2026-09-14T16:17:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146964

Researchers from FDA and several drug companies summarized FDA’s past acceptance of real-world data sources for supporting drug approval in new indications that have been reflected in U.S. labels. Writing in *Therapeutic Innovation & Regulatory Science*, the researchers [say](https://doi.org/10.1007/s43441-020-00170-y?ref=fdaweb.com) their summary focuses on the type of real-world data and statistical methodologies presented in the labels.

Through in-depth assessment of the real-world evidence presented in two specific labels, they demonstrate the issues that can be raised in data collection that could affect interpretation. They also include a brief discussion of statistical methods that can be used to incorporate real-world evidence into clinical development.

“Our findings clearly support the idea that real-world data/real-world evidence can be used in the label,” the researchers conclude.