The U.S. Food and Drug Administration (FDA) published a notice in the Federal Register today seeking comments on its draft IT strategy, with plans to publish the official strategy by Sept. 29.
FDA said the strategy – titled the “FDA Data and Technology Strategic Plan” – will define and shape the future course of the agency’s data and tech capabilities for fiscal years 2024 to 2026.
“The agency took a collaborative approach to strategy development by gathering input from numerous internal and external stakeholders that resulted in the draft FDA IT Strategy,” the request for comment says.
“Stakeholder input is crucial for developing a comprehensive plan that best meets the needs and goals of industry and the agency. Comments on the strategy will be considered for future iterations of the FDA IT Strategy,” it explains. “Once adopted, this strategy will serve as the basis for developing an internal operational plan with objectives, tactics, and performance measures.”
The plan has six strategic goals, including to create a shared “OneFDA” ecosystem, which would encourage shared resources and data; strengthen IT infrastructure, continuing to modernize and secure IT systems; and modernize enterprise services and capabilities, optimizing the IT services portfolio.
The other goals are to share data for mission outcomes, identifying common data assets across FDA; adopt AI and mission-driven innovations, driving exploration of emerging technologies; and cultivate talent and leadership, maturing agency-wide IT competencies to deepen technology expertise.
The FDA encouraged stakeholders to submit comments that detail what goals and objectives they believe are most important, as well as what gaps they see in the IT strategy’s goals or objectives.
FDA plans to hold an FDA Digital Transformation Symposium on Dec. 4 to 7 to discuss the new strategy. The agency said Dec. 4 and 5 will focus on the six new strategic goals, while Dec. 6 and 7 will engage IT vendors in a “Reverse Industry Day and other vendor-focused events.”
Comments on the strategy are due by Oct. 30, to ensure that the FDA considers the comments on this strategy for “future iterations of the IT strategy.”