SILVER SPRING, Md. , Sept. 15, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). This office will now report directly to FDA Commissioner, elevating it and its functions to agency level. This restructuring will help the agency achieve its information technology transformation. It will provide better data and IT capabilities that will improve agency operations in support of the public health mission.
This reorganization marks a major step in the FDA’s technology and data modernization efforts, which began over two years ago.
The FDA’s reorganization will allow it to provide more efficient and effective data and IT management. It is based on best practices to improve and streamline FDA operations. This includes reducing duplicative processes, using technological efficiencies to deliver maximum customer benefits, and encouraging shared services within agency offices. This will help the agency to secure and strategically advance its regulatory mission.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D., “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do. The FDA is better able to ensure the safety of America’s food, drugs and medical devices. This restructuring strengthens our commitment towards public health and promotes public safety by improving regulatory processes that have a solid data foundation at all levels. “
The FDA has been undertaking a modernization effort since September 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 medical product applications, food safety 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. The agency has also announced the appointment of Vid Desai to the position of Chief Information Officer.
The FDA FY 2022 budget request included funding to support the agency’s data and IT modernization efforts for enterprise-wide data modernization, demonstrating the commitment to and the progress of these institutional changes.
- Office of Digital Transformation
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SOURCE U.S. Food and Drug Administration