FDA launches COVID-19 research initiative

The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19.

The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.

“The FDA is approaching the generation of real-world evidence for COVID-19 with a sense of urgency to learn what we can, as soon as we can, from patients who are receiving care right now,” said FDA principal deputy commissioner Amy Abernethy in a news release. “We also recognize that COVID-19 is a dynamic situation. We can use current data and learn what decisions we can confidently make now, and we can learn what we’ll need to do in the future as more data become available.”

Aetion and the FDA will identify and analyze fit-for-purpose data sources to characterize COVID-…

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