FDA issues first recommendations on AI for drug development

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines. FDA has previously published a discussion paper that was produced to inform its guidance on AI in pharmaceutical drug development.

The framework is aimed at helping sponsors to assess and establish the credibility of an AI model. In light of this and considering the range of potential applications of AI modelling, “defining the model’s context of use is critical”, according to the FDA.

For example, AI approaches can be used to process and analyse large datasets (eg, real-world data sources or data from digital health technologies), the agency highlighted.

Promoting innovation in pharma with artificial intelligence (AI)

“The FDA is committed to supporting innovative approaches for the development of medical products by providing an agile, risk-based framework that promotes innovation and ensures the agency’s robust scientific and regulatory standards are met,” commented FDA Commissioner Dr Robert Califf. “With the appropriate safeguards in place, artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care.”

As a draft framework, the FDA is seeking public comment on this new guidance.

The US regulatory agency stated that it is particularly interested in feedback “on how well this draft guidance aligns with industry experience and whether the options available for sponsors and other interested parties to engage with the FDA on the use of AI are sufficient” for drug development.