FDA announces new ‘Office of Digital Transformation’

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The U.S. Food and Drug Administration has announced the reorganization of the agency’s information technology, data management and cybersecurity functions into the new Office of Digital Transformation (ODT).

According to acting FDA Commissioner Janet Woodcock, M.D., “Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families.”

The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level. This reorganization will advance the agency’s information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission.

The reorganization is part of the FDA’s technology and data modernization efforts that began more than two years ago. The reorganization allows the FDA to bring more effective and efficient data and IT management, built on best practices, to streamline and advance FDA operations by reducing duplicative processes, implementing technological efficiencies using projects that deliver the most customer benefits, and promoting shared services within agency offices and centers to strategically and securely further the agency’s regulatory mission.

“By prioritizing data and information stewardship throughout all of our operations,” Woodcock said, “the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products that the FDA regulates in this complex world.”

About the technology and data modernization plans
The FDA has been undertaking a modernization effort since Sept. 2019, with the Technology Modernization Action Plan, which laid the groundwork for the more modern approach to the use of technology for the agency’s regulatory mission, including looking at innovative ways for the review of food safety, medical product applications, and other critical functions.

That was followed by the Data Modernization Action Plan, announced earlier this year, which built upon the successful streamlining and process improvements started in 2019 to identify and execute high-value driver projects for individual centers and for the agency. As part of the establishment of this new office, the agency is also announcing the appointment of Vid Desai as the agency’s new Chief Information Officer.

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