RWE Alliance’s Response to FDA’s Draft Guidance on EHR/Claims Data Now Available

February 7, 2022

The Real-World Evidence (RWE) Alliance’s comments on the United States Food and Drug Administration’s (FDA) draft guidance regarding RWE and regulatory decision-making are now available. The draft guidance, entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products” lays out a pre-definition process wherein study designers will designate and communicate essential elements and statistical analysis plans to the FDA earlier in the approval process, a move which the RWE Alliance supports.

According to the RWE Alliance’s comments, “This approach enhances confidence in RWE study results by reducing the risk of a results-driven selection of study parameters.4 In addition, integrating transparent, auditable, reproducible, and scientifically valid RWE into regulatory decision-making will facilitate more efficient drug development and enhance understanding of product safety and effectiveness. We appreciate that the Draft Guidance identifies these and other key elements that are necessary components of RWE studies in order to support FDA decision-making.”

To read their entire comments, click here.

(Source: FDA, January 24th, 2022)

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