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November 29, 2021

In comments submitted to the Food and Drug Administration (FDA), AMIA applauded the scientific rigor and thoughtfulness with which FDA approached its draft guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products Draft Guidance.” AMIA made several recommendations to clarify and improve the guidance, to ultimately further encourage industry to leverage Real-World Data.