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Real-World Data: US FDA Gets 2 Out Of 10 In Abernethy’s Self-Assessment Of COVID Usage

Executive Summary

But principal deputy commissioner gives FDA an ‘8 or 9 on vision’ of how to use RWD to address the pandemic and other challenges. The low ‘execution’ score is due to the large amount of effort needed to understand what datasets are available, how they can be used with confidence and what questions they can answer, Abernethy says.

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