FDA Releases Draft Guidance on RWD in Pharma Submissions

October 19, 2021

The Food and Drug Administration (FDA) has released its draft guidance on real world data (RWD). The guidance is intended to support submissions that incorporate data from electronic health records (EHRs) and medical claims data. The document highlights data sources, successfully capturing and validating data, and selecting appropriate measures of outcomes.

“This guidance provides recommendations on selecting data sources to maximize the completeness and accuracy of the data derived from EHRs and medical claims for clinical studies.” Read the draft guidance here.

(Source: FDA, 9/21)

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