FDA’s Guidance on Using RWD in Evidence Generation Is a Big Step Forward

\n\nReal world data (RWD) has been used for more than four decades to expand knowledge about a variety of research questions in healthcare—from disease epidemiology to the performance of treatments and devices in real world settings. This data can play a definitive role in generating evidence, provided the data sources are thoroughly vetted, fit-for-purpose, and the datasets match both the specific research question and the specific regulatory need.\n\nIn September and October, FDA issued new guidance about assessing electronic health record (EHR) and claims data and data standards for submissions containing RWD. This action shows the agency …

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2021-12-08 22:36:00