The Food and Drug Administration (FDA) is pleased to present the Information Technology (IT) Strategy for Fiscal Years 2024 to 2027. Led by the Office of Digital Transformation, this vital initiative is the next step in our technological advancement, aligning with our commitment to enhance public health.
Building on a Strong Foundation
The existing FDA Modernization Framework is the cornerstone of our new strategy, focusing on technology, data, cybersecurity, enterprise transformation, and leadership. This work builds on the principles of the Technology Modernization Action Plan, Data Modernization Action Plan, Enterprise Modernization Action Plan, Cybersecurity Modernization Action Plan, and Leadership Modernization Action Plan. It fulfills the agency’s Prescription Drug User Fee Act (PDUFA) Reauthorization 2023-2027 PDUFA VII Commitment Letter and Fiscal Year 2023 Omnibus Bill commitments to create an agency-wide IT strategic plan.
A Shared Vision
This plan is more than a roadmap; it is a shared FDA vision for excellence. This unified approach will innovate and enhance public health outcomes. With technology playing a pivotal role in food, drug, and medical devices' safety, our strategy emphasizes Artificial Intelligence (AI) and other emerging technologies. By being agile and forward-thinking, the FDA aims to adapt to emerging technologies, ensuring continuous safeguarding of the American people.
Our plan focuses on six key goals, including:
- Enhancing Collaboration: Create a Shared OneFDA Ecosystem.
- Strengthening Infrastructure: Modernize and secure IT infrastructure.
- Modernizing Services: Optimize IT services for stability and adaptiveness.
- Sharing Data: Drive efficiency and innovation.
- Adopting AI and Innovations: Embrace emerging technologies.
- Cultivating Talent and Leadership: Develop technology expertise and leadership.
We're embracing a bold shift towards collaboration and transformation. From undertaking an enterprise IT Assessment to creating a new Technology Business Management (TBM) Center of Excellence, our strategy aligns resources for efficiency and excellence. With this strategy, we're not just planning the future – we're committing to innovate, transform, and leverage data and technology to improve health for all.