FDA Information Technology Strategy for FY 2024 – FY 2027
Unlocking Potential, Leading Transformation
The U.S. Food and Drug Administration (FDA) is proud to announce the release of our Information Technology (IT) Strategy for Fiscal Years 2024 to 2027 annual refresh. This comprehensive plan represents a significant milestone in our ongoing journey to enhance and modernize FDA's technological capabilities.
A Collaborative Effort
Our IT strategy is a result of extensive collaboration across FDA's centers and offices, incorporating valuable input from hundreds of internal and external stakeholders. This inclusive approach ensures that our plan is robust and aligned with our organization's diverse needs, making each stakeholder a crucial part of our journey. This document 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.
Strategic Goals
Our plan focuses on six key goals, including:
- Create a Shared One FDA Ecosystem.
- Strengthening IT Infrastructure
- Modernize Enterprise Services and Capabilities
- Share Data for Mission Outcomes
- Adopt AI and Mission-Driven Innovations
- Cultivate Talent and Leadership
Looking Ahead
The FDA’s IT Strategy reflects a bold, ambitious set of goals that focuses on strengthening the FDA’s foundation while preparing for the future. By the end of 2027, the FDA's IT Strategy aims to advance the FDA’s public health mission through enabling timely regulatory decisions, operational efficiencies in regulatory processes, increased public engagement and trust, and innovative and informed public health responses at enterprise scale.