Top FDA Officials Tout Use Of Real-World Evidence Based On New Report

The report looks at a broad range of submission and product types and concludes use of RWE/RWD has helped get new products to market faster.

A sign with the words "The Real World" with a cloudy sky backdrop

A review of 90 medical device and diagnostics submissions that used real-world evidence or real-world data shows that RWE/RWD can be a powerful tool to not only better understand how products work outside the clinical trial setting, but also get treatments to patients faster, the US Food and Drug Administration says.

Over the past few years, the agency has heavily touted the benefits of using RWE to medtech sponsors at various forums and even developed the National Evaluation System for Health...

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