The U.S. Food and Drug Administration has embarked on a project that the agency considers critical for its future: the modernization of its IT platforms to get ready to handle the enormous data sets the FDA receives each day from healthcare providers, product manufacturers, regulatory groups and other organizations.

The growth of these datasets is due to the integration of new submissions such as marketing applications—often containing clinical trial and animal study data—and adverse event reports into existing databases, as well as the rising numbers of submissions each year, says Taha Kass-Hout, chief health informatics officer at the FDA, who’s responsible for overseeing the agency’s big data and analytics initiatives.

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