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# New CDER Office Focused on AI, Real-World Evidence
- URL: https://www.fdaweb.com/new-cder-office-focused-on-ai-real-world-evidence/
- Published: 2026-10-02T23:51:00.000Z
- Updated: 2026-10-03T01:33:57.000Z
- Author: David McFarland
- Tags: Drugs

CDER has launched a new Office of Innovation and Clinical Trial Modernization (OICTM), including dedicated divisions for artificial intelligence and real-world evidence analytics.

The office became operational 10/1 within CDER’s Office of Medical Policy, coinciding with the start of the new federal fiscal year. Its creation was foreshadowed in a 7/29 *Federal Register* [notice](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.federalregister.gov/documents/2026/07/29/2026-15297/statement-of-organization-functions-and-delegations-of-authority&ved=2ahUKEwiIrtrv15yXAxUSFFkFHQ25H%5FMQFnoECBkQAQ&usg=AOvVaw1xdRU6i0Zfxg8mgBol3sx1) formally revising FDA’s organizational structure. The notice identified OICTM and its two divisions but did not describe their specific functions, staffing or regulatory responsibilities.

The new structure formalizes several areas that already have been major priorities for the Office of Medical Policy, including innovative clinical trial designs, real-world data and evidence, and the use of AI in drug development.

FDA has increasingly focused on AI’s potential role in clinical research. The agency has said AI and machine learning are being integrated into clinical trial design, digital health technologies and real-world data analytics. FDA also has developed recommendations for using AI-generated information to support regulatory decisions on the safety, effectiveness and quality of drugs and biologics.

The Division of Real-World Evidence Analytics similarly builds on an established CDER program. FDA has developed a series of guidances and demonstration projects addressing the use of electronic health records, claims, registries and other real-world data to generate evidence supporting regulatory decisions.

In a 10/1 LinkedIn post, **Marie Bradley** announced that she has been named acting director of the Division of Real-World Evidence Analytics. Bradley previously served as senior advisor for RWE in the Office of Medical Policy, where her responsibilities included leading the Advancing Real-World Evidence Program and Real-World Evidence Subcommittee and overseeing a portfolio of RWE demonstration projects. She also evaluated complex RWE-related study protocols submitted to the agency.