The US Food and Drug Administration (FDA) has proposed a framework to advance the credibility of artificial intelligence (AI) models used in drug and biological product submissions. The guidance aims to support regulatory decision-making on safety, effectiveness, or quality while ensuring robust scientific standards.
The FDA acknowledges its substantial experience with AI components in drug development and submissions since 2016. AI can be applied to predict patient outcomes, improve disease progression understanding, and analyze large datasets. However, the model’s credibility is a key consideration.
To address this, the FDA provides a risk-based framework for sponsors to assess and establish AI model credibility. This approach aligns with existing agency practices. The agency encourages early engagement on AI credibility assessment or its use in human and animal drug development.
The guidance was developed through collaboration between the FDA’s human and animal medical product centers, as well as other offices, incorporating feedback from industry stakeholders, academia, and experts. The FDA seeks public comment on the draft guidance within 90 days to ensure alignment with industry experience and sufficient engagement options.
This announcement is part of the FDA’s efforts to promote responsible AI use in medical products while supporting innovation.
Source: https://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissions