Story perspectives

FDA Approves Real-World Evidence for Drug Applications

12/16/2025

Summary

Story summary

The U.S. Food and Drug Administration (FDA) announced on December 15, 2025 that it will permit real-world evidence in drug and device applications without identifiable patient data.
FDA Commissioner Marty Makary stated the reform aims to expedite approvals and cut costs by using de-identified databases such as cancer registries and insurance claims.
The policy follows years of limited real-world evidence use, noting only 12 drugs included it in the last 14 years.

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Story summary

The U.S. Food and Drug Administration (FDA) announced on December 15, 2025 that it will permit real-world evidence in drug and device applications without identifiable patient data.
FDA Commissioner Marty Makary stated the reform aims to expedite approvals and cut costs by using de-identified databases such as cancer registries and insurance claims.
The policy follows years of limited real-world evidence use, noting only 12 drugs included it in the last 14 years.