FDA reorganization creates dedicated divisions for AI and real-world evidence analytics

The US FDA has established dedicated divisions for AI and real-world evidence (RWE) analytics within a new Office of Innovation and Clinical Trial Modernization, bringing these areas together with clinical methodology expertise to support drug development and regulatory decision-making.

The Baseline

• The FDA has established dedicated AI and RWE Analytics divisions within its new Office of Innovation and Clinical Trial Modernization, operational since October 1, 2026.
• Marie Bradley serves as acting director of the RWE Analytics division, while Hussein Ezzeldin leads the AI division.
• The reorganization coincides with a new FDA Transparency Roadmap, which includes plans to increase visibility into how RWE is used in regulatory submissions.

The US FDA has created two divisions focused on AI and RWE analytics as part of a reorganization of its Center for Drug Evaluation and Research (CDER). Both sit within the newly established Office of Innovation and Clinical Trial Modernization (OICTM), giving these areas a dedicated organizational structure alongside work on clinical trial methodology.

The office began operating on October 1, 2026. Its establishment was outlined in a July 29 Federal Register notice revising the agency’s organizational structure, which listed OICTM, its two divisions and the Clinical Methodology Staff. The notice did not set out detailed responsibilities for the new divisions.

The changes bring together several established priorities for CDER’s Office of Medical Policy, including innovative trial designs, the use of real-world data (RWD) in evidence generation and the application of AI in drug development.

Dianne Paraoan, Acting Director for the Office of Medical Policy (OMP) at CDER explained that the reorganization builds on the office’s existing responsibilities, writing on LinkedIn:

“While our overall functions haven’t changed, with OICTM we are now given an opportunity to continue to push the needle forward and promote the integration of emerging tools and innovative trial design as an office within OMP/CDER.”

Marie Bradley (FDA) has been appointed acting director of the Division of Real-World Evidence Analytics. Announcing her new role on LinkedIn, Bradley highlighted the opportunity to build on her work supporting the use of RWE in regulatory decisions.

“I look forward to the important work ahead in advancing the use of real-world evidence in regulatory decision-making and I’m deeply grateful to the colleagues, mentors, and friends who have supported me along the way,” she wrote.

Alongside leading the new division, Bradley chairs the Real-World Evidence Subcommittee and leads the Advancing Real-World Evidence Program and a portfolio of RWE demonstration projects. She also co-chairs the agency-level FDA-RWE-ACCELERATE initiative and contributes to national and international discussions on the use of RWE through external engagement.

Hussein Ezzeldin (FDA) leads the new Division of Artificial Intelligence. In a LinkedIn post announcing his appointment, he described himself as “very honored and humbled” to take on the role. He emphasized collaboration with the wider drug development community, with the goal of “getting effective and safe treatments to Patients faster.”

One potential area of focus for the new division is advancing the FDA’s draft guidance on AI use in drug and biological product development, issued in January 2025. The guidance proposes a risk-based framework for assessing the credibility of AI models used to generate information supporting regulatory decisions. Progressing this work could help clarify expectations for developers, although the division’s role in taking the guidance forward has not been announced.

The reorganization coincides with the release of the FDA’s Transparency Roadmap, which outlines progress during fiscal year 2026 and priorities for 2027. Under its focus on new approach methodologies and novel biomarkers, the agency will continue to provide greater visibility into the use of RWE in regulatory submissions and decentralized trials that generate evidence through digital health technologies.

The roadmap highlights annual reports on aggregate and anonymized RWE submissions to CDER and the Center for Biologics Evaluation and Research (CBER), published in line with PDUFA VII commitments. These reports aim to give the wider research and development community a clearer picture of how RWE contributes to regulatory decisions on effectiveness and safety.