FDA Establishes AI Council to Improve Regulatory System

As artificial intelligence (AI) has become a big driver of healthcare and biomedicine, regulators have new concerns. There has been a substantial increase in submissions that contain AI or ML over the past several years to FDA's Center for Drug Evaluation and Research (CDER).

For the sake of oversight and integration in drug discovery, CDER Director Cavazzoni issued an internal email to his team formalising the establishment of an AI Council. The AI Council will merge existing AI organizations to integrate all AI-based activities. The AI Council will bring together experts from across the fields of regulation, data, and clinical trials. The AI Council will soon take stock of all AI-related projects, expand the tracking of AI work, and establish a unified process for future AI projects.

Responsibilities of the AI Council

• The AI Council is responsible for overseeing and improving the existing regulatory system for AI and ML products, involving the development and supervision of AI policies related to regulatory decisions.
• The AI Council is responsible for overseeing the application of AI in the process of drug development, including drug discovery, screening, non-clinical research and other processes.
• The AI Council ensures consistency of internal and external AI-related activities, such as the criteria used to assess the safety, efficacy, and quality of medicines.
• The AI Council oversees AI capabilities within regulators, including technology, data, algorithms, and models, to advance innovative uses of AI technology.
• As a centralized resource for information collection and dissemination within and from the center, the AI Council will handle inquiries from external stakeholders.
• The AI Council will establish a centralised process for offices to seek advice and support on future AI initiatives.
• Due to the rapid development of AI and changes in the external environment, the AI Council needs to meet new governance requirements to accommodate new applications of AI in drug development.
• The AI Council will provide a coherent voice for CDER to communicate with the public and industry on AI issues.

The scope and influence of AI in drug development are expanding. The AI Council can effectively integrate the regulatory process of AI drug development, which marks an important step for FDA in the regulation of AI-related drug development.

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