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US FDA Searches For Consistency On Assessment Of Real-World Evidence

 
• By Derrick Gingery

As more sponsors begin using RWE, the agency is establishing procedures and training to ensure assessors consistently apply policies.

Archery
The US FDA is employing a similar approach to ensure assessor consistency as it did with rare diseases.

The US Food and Drug Administration may be leading efforts to increase use of real-world evidence, but also expects its own staff will need further education on the subject.

An internal FDA committee is ensuring applications including real-world evidence are handled the same way throughout the review divisions

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