University of North Carolina comments on draft FDA RWE guidance

Written by Darcy Hodge, Editor

RWD

Following the notice from the FDA entitled “Real-world data: assessing electronic health records and medical claims data to support regulatory decision-making for drug and biological products; draft guidance for industry; availability”, faculty from the University of North Carolina at Chapel Hill (NC, USA) have provided feedback about the use of the guidance to assess RWD. The response from staff at the University of North Carolina is based on their expertise in using real-world evidence (RWE) and improving the methodology used to generate RWE.  First, commendations were given to the guidance for offering insight into aspects of ensuring real-world data (RWD) is fit for purpose. However, concerns were raised about the ideals expressed in the guidance. Staff...

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