FDA Concludes Scientific Review Pilot Project with AI and Prepares for Transversal Implementation by June 2025
The Food and Drug Administration (FDA) has announced the completion of the first artificial intelligence (AI)-assisted scientific review pilot project and unveiled an ambitious plan to expand the internal use of this technology across the agency by June 30, 2025.
The pilot project was conducted by the Center for Drug Evaluation and Research (CDER) and tested the use of generative AI as a tool to support scientific reviewers. The aim: to increase efficiency, reduce the time spent on repetitive tasks and strengthen the technical quality of reviews.
According to the FDA, tasks that used to take up to three days to complete manually can now be completed in minutes with AI support. This approach is not intended to replace specialists, but to increase analytical capacity, allowing reviewers to focus on scientific evaluation with greater added value.
AI with Responsibility: Safety, Privacy and Human Control
The FDA emphasizes that the adoption of AI will be done through a unified and secure internal platform, with a focus on:
Data privacy and cybersecurity;
Traceability and validation of AI outputs;
Continuous human supervision;
Customization by center or department.
The agency undertakes to maintain compliance with its own information security policies and with the fundamental principles of trust and responsibility.
New strategic leadership in AI at the FDA
The implementation is being coordinated by Jeremy Walsh, recently appointed Chief Artificial Intelligence Officer of the FDA, and Sridhar Mantha, former Director of Enterprise Informatics at CDER. Both have experience leading large-scale technology programs in federal health and science agencies.
What can we expect in the coming months?
Expansion of generative AI functionalities to other FDA centers;
Integration with existing workflows;
Structured collection of feedback from internal users;
Further details and technical updates will be published in June 2025.
Opportunity for Industry: Why does this matter to manufacturers?
Although this initiative is aimed at the internal modernization of the FDA, manufacturers and holders of regulatory processes in the US should anticipate the impacts:
Expectations of faster and more objective responses from reviewers;
Greater focus on structured, clear and traceable documentation;
Potential adaptation of submission models to align with AI-based decision support tools;
Confirmation of the global trend towards digitalization and modernization of regulatory assessment processes.
Read the full article at the following link: https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai
