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1 https://www.fda.gov/about-fda/what-we-do
2 UCB considers RWE to be any clinical and/or economic findings with respect to disease burden, treatment utilization and outcomes, comparative effectiveness, etc. that analyzes real-world data. Real-world data includes, but is not limited to, medical and pharmacy administrative claims, electronic medical/health records, product/disease registries, and patient-reported outcomes collected through various channels. Methods and analytical approaches (including artificial intelligence) to real-world data collection and RWE generation can vary but acknowledge that RWE must be appropriately executed based on proposed research objectives and be fit for purpose.