FDA Proposes New Framework for AI Models in Drug and Biological Product Development
The U.S. Food and Drug Administration has introduced draft guidance aimed at bolstering the credibility of AI models used in drug and biological product development. This marks a significant milestone as the agency’s first official guidance on using AI to support regulatory decisions regarding the safety, effectiveness, and quality of medical products.
In a statement, FDA Commissioner Robert M. Califf, M.D., emphasized the agency’s commitment to innovation:
“With the appropriate safeguards in place, artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care.”
A Risk-Based Approach to AI Credibility
The FDA’s framework focuses on the “context of use,” which defines how an AI model addresses specific questions during the drug development process. This approach ensures that sponsors can assess the reliability of AI models in various applications, such as predicting patient outcomes or analyzing complex datasets.
The draft guidance provides recommendations for determining the activities required to establish an AI model’s credibility. These guidelines are consistent with the FDA’s ongoing review process for drug and biological product submissions that include AI components.
The agency encourages early engagement from sponsors to discuss AI credibility assessments and explore its use in human and animal drug development.
Broad Collaboration and Stakeholder Input
The FDA developed this guidance through collaboration across its medical product centers, including the Office of Inspections and Investigations, Oncology Center of Excellence, and Office of Combination Products.
Input was gathered from sponsors, technology developers, academics, and manufacturers. Notably, more than 500 submissions with AI components since 2016 and over 800 public comments contributed to shaping the draft.
The agency also benefited from insights shared during an FDA-sponsored workshop convened by the Duke Margolis Institute for Health Policy in December 2022.
Call for Public Feedback
The FDA is seeking public comments on the draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, within 90 days. Feedback will help ensure alignment with industry practices and refine engagement options for stakeholders.
Additionally, the agency released a separate draft guidance addressing AI-enabled medical devices, underscoring its comprehensive approach to integrating AI into healthcare.
Pioneering the Ethical Use of AI
The FDA’s efforts highlight a broader mission to promote the responsible and ethical use of AI in healthcare. As AI continues to evolve, the agency remains focused on developing policies that balance innovation with its rigorous standards for safety and effectiveness.
For more information, visit the FDA’s resources on artificial intelligence and medical products:
- Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
- Artificial Intelligence and Medical Products
Closing Thoughts
By establishing a robust framework for AI credibility, the FDA is paving the way for transformative advancements in drug development while maintaining public trust and safety. This forward-thinking approach reflects the agency’s dedication to fostering innovation in a rapidly evolving field.
