FDA Establishes AI Council to Oversee Ongoing and Future AI Projects

FDA's AI Council Formation:
The FDA has formed a new council to house all ongoing and future AI projects, aiming to streamline and coordinate AI efforts across the agency.

Digital Health Advisory Committee:
The FDA is establishing a Digital Health Advisory Committee to advise on issues related to digital health technologies, including AI and machine learning. The committee will hold its inaugural meeting on November 20-21, 2024, to discuss the impact of Generative AI on medical devices.

Draft Guidance on AI:
The FDA's Center for Drug Evaluation and Research (CDER) is preparing to release a draft guidance on the use of artificial intelligence to support regulatory decision-making for drug and biological products. This guidance is based on the FDA's experience with over 300 AI-related submissions and feedback from industry stakeholders.

AI Development Lifecycle Framework:
The FDA emphasizes the importance of adopting standards and best practices for the AI development lifecycle to reduce risks associated with AI models. This includes ensuring data quality, model transparency, and continuous performance monitoring.

Advanced Manufacturing and AI:
The FDA is also exploring the use of AI in advanced manufacturing technologies to improve drug quality, address shortages, and speed time-to-market. This includes hosting workshops and releasing discussion papers to facilitate dialogue among stakeholders.