Biologics

CBER AI/ML Web Page

CBER has launched a Web page describing its approach to artificial intelligence and machine learning (AI/ML) for biological and other products regulated by the Center. The page says the Center has participated in public workshops and discussions organized by FDA and other national and international organizations to better understand the uses of AI/ML in biologics and inform an appropriate regulatory framework that advances safe and responsible use and promotes innovation.

The page notes that addressing the full potential of AI/ML is a coordinated effort within FDA. In coordination with others in the agency, it says, CBER is developing a regulatory framework for the safe and responsible use of AI throughout the biological product lifecycle.

“CBER supports the validated use of AI/ML throughout the product lifecycle to expedite product development and approval, and support effective product oversight,” the page says…. “Since 2016, CBER has identified an increasing use of AI/ML in IND submissions of vaccines, cellular products, and gene therapies. Currently, we have over 70 IND applications with AI/ML, used in various disciplines that involve prediction, classification, clustering, and anomaly detection. CBER, in collaboration with other medical product centers, continues to develop and apply a risk-based approach to review of AI/ML in regulatory submissions. This approach will incorporate framework, best practices, and consider the AI/ML technology, its specific application, and product and clinical considerations.”

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