The U.S. Food and Drug Administration (FDA) has recently released draft guidance offering recommendations for the use of artificial intelligence (AI) in supporting regulatory decisions related to the safety, effectiveness, or quality of drugs and biological products. 

This marks the agency’s first guidance specifically addressing the application of AI in the development of drugs and biologics.

“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. With the appropriate safeguards in place, artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care,” FDA Commissioner Robert M. Califf, M.D., said.

The FDA believes AI can support drug and biologic development by predicting patient outcomes, identifying disease progression factors, and analyzing large datasets from real-world or digital health sources. Hence, defining its context of use is essential.

This guidance outlines a risk-based framework for sponsors to evaluate an AI model’s credibility, establish its suitability for a specific context, and determine the credibility of the AI model’s output.

Last year, the FDA joined hands with the U.S. Department of Veterans Affairs (VA) to create an AI lab focused on evaluating and advancing promising emerging technologies in the healthcare sector.

The lab will serve as a valuable resource for both federal agencies and the private sector, providing a virtual environment to test AI applications.