FDA's IT Strategy: Unlocking Potential, Leading Transformation – FDA.gov
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By: Vid Desai, Chief Information Officer and Jessica N. Berrellez, Executive Officer
The U.S. Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency’s technological advancement and the alignment with its broader public health mission. The IT Strategy fulfills commitments under the FDA’s Prescription Drug User Fee Act (PDUFA VII) reauthorization for fiscal years (FYs) 2023-2027 and obligations under section 3627 of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023. Led by the FDA’s Office of Digital Transformation with input from FDA centers and external stakeholders, the plan is both ambitious and collaborative, designed to meet the diverse needs of its internal and external constituents.
The FDA’s existing IT modernization framework is a cornerstone for the new strategy. This robust foundation focuses on critical aspects such as technology, data, enterprise management, cybersecurity, and leadership and has already advanced the FDA’s technology maturity. The agency considers the new IT Strategy more than a roadmap: it’s a shared vision that unites the FDA’s IT portfolio and will foster innovation, enhance public health outcomes, and lead the FDA into a new era of scientific and technological advancement. The new IT Strategy also embraces the agency’s proposed plan to develop a unified Human Foods Program and new Office of Regulatory Affairs model.
In a rapidly evolving landscape, technology’s role in assuring the safety and efficacy of food, medical products, and all products that the FDA regulates, is more significant than ever. The IT Strategy will guide the agency as we transform our IT in alignment with business capabilities and needs, modernizing critical systems, enabling data sharing, and leveraging emerging technologies like Artificial Intelligence (AI).
The FDA’s IT must adapt to changes in demand, scarcity of technical talent, emerging technologies, and the need for robust governance. The increased availability and use of big data and large language models to make data-informed decisions is ushering in a new era of possibilities. By being agile and forward-thinking, the FDA aims to bridge the gap between current capabilities and rapid technological advancements, enhancing our ability to protect public health.
The IT Strategy for Fiscal Years 2024 to 2027, revolves around six key goals:
The IT Strategy represents a bold paradigm shift towards a shared enterprise approach, fostering collaboration and continuous transformation in collaboration with our external cross-sector partners and stakeholders. The FDA will host the FDA Digital Transformation Symposium on December 4-6, 2023, to inform and engage the public on this exciting new agenda.
With a shared vision, modernized infrastructure, a focus on innovation and dedication to talent cultivation, the FDA’s IT portfolio will help strengthen the next phase of the agency’s evolution. The collaborative spirit that shaped this plan is a testament to our shared commitment to the health and safety of the American people.
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This article was autogenerated from a news feed from CDO TIMES selected high quality news and research sources. There was no editorial review conducted beyond that by CDO TIMES staff. Need help with any of the topics in our articles? Schedule your free CDO TIMES Tech Navigator call today to stay ahead of the curve and gain insider advantages to propel your business!
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
By: Vid Desai, Chief Information Officer and Jessica N. Berrellez, Executive Officer
The U.S. Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency’s technological advancement and the alignment with its broader public health mission. The IT Strategy fulfills commitments under the FDA’s Prescription Drug User Fee Act (PDUFA VII) reauthorization for fiscal years (FYs) 2023-2027 and obligations under section 3627 of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023. Led by the FDA’s Office of Digital Transformation with input from FDA centers and external stakeholders, the plan is both ambitious and collaborative, designed to meet the diverse needs of its internal and external constituents.
The FDA’s existing IT modernization framework is a cornerstone for the new strategy. This robust foundation focuses on critical aspects such as technology, data, enterprise management, cybersecurity, and leadership and has already advanced the FDA’s technology maturity. The agency considers the new IT Strategy more than a roadmap: it’s a shared vision that unites the FDA’s IT portfolio and will foster innovation, enhance public health outcomes, and lead the FDA into a new era of scientific and technological advancement. The new IT Strategy also embraces the agency’s proposed plan to develop a unified Human Foods Program and new Office of Regulatory Affairs model.
In a rapidly evolving landscape, technology’s role in assuring the safety and efficacy of food, medical products, and all products that the FDA regulates, is more significant than ever. The IT Strategy will guide the agency as we transform our IT in alignment with business capabilities and needs, modernizing critical systems, enabling data sharing, and leveraging emerging technologies like Artificial Intelligence (AI).
The FDA’s IT must adapt to changes in demand, scarcity of technical talent, emerging technologies, and the need for robust governance. The increased availability and use of big data and large language models to make data-informed decisions is ushering in a new era of possibilities. By being agile and forward-thinking, the FDA aims to bridge the gap between current capabilities and rapid technological advancements, enhancing our ability to protect public health.
The IT Strategy for Fiscal Years 2024 to 2027, revolves around six key goals:
The IT Strategy represents a bold paradigm shift towards a shared enterprise approach, fostering collaboration and continuous transformation in collaboration with our external cross-sector partners and stakeholders. The FDA will host the FDA Digital Transformation Symposium on December 4-6, 2023, to inform and engage the public on this exciting new agenda.
With a shared vision, modernized infrastructure, a focus on innovation and dedication to talent cultivation, the FDA’s IT portfolio will help strengthen the next phase of the agency’s evolution. The collaborative spirit that shaped this plan is a testament to our shared commitment to the health and safety of the American people.
Subscribe to receive FDA Voices email notifications.
This article was autogenerated from a news feed from CDO TIMES selected high quality news and research sources. There was no editorial review conducted beyond that by CDO TIMES staff. Need help with any of the topics in our articles? Schedule your free CDO TIMES Tech Navigator call today to stay ahead of the curve and gain insider advantages to propel your business!
