The FDA and Aetion will pull data from sources including EHRs, insurance claims, patient registries and lab results. By evaluating this data, the partners aim to answer questions about the use of diagnostics and medications in the pandemic as well as risk factors for COVID-19-related complications in different patient populations.
“Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages,” the FDA news release states.
Through the research, FDA aims to support ongoing work to evaluate potential therapies, vaccines and diagnostics for COVID-19. The agency also plans to use the data to reduce potential medical product and food supply chain shortages as well as verify safety and quality of FDA-regulated products.
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