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FDA Weighs How to Apply Real-World Evidence to Regulatory Calls

August 1, 2016

The FDA is clarifying how it plans to evaluate real-world evidence to determine when it could be used to support regulatory decisions for medical devices.

Real-world data collected from sources outside of traditional trials, including retrospective studies, registries, electronic health records and other sources, could provide enough evidence for regulatory decisions; the FDA said in draft guidance.

Although real-world evidence gathered from real-world data elements could constitute valid scientific evidence, the agency said, it is not changing its evidentiary standards in any way. — Tamra Sami

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