Clarkston Shares Guest Column on Use Of AI To Support Regulatory Decision-Making
February 14, 2025 | Clarkston Consulting’s Susan Shockey recently shared a guest column with Clinical Leader on the use of AI to support regulatory decision-making. Read an excerpt below and the full article here.
FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products
“The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.1 The FDA stated in the federal register announcement2 that it recognizes that the use of artificial intelligence (AI) in drug development is broad and rapidly evolving. This guidance proposes a risk-based credibility assessment framework relating to AI technologies, the data used to train the technologies, and governance around the technologies that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU). When finalized, this guidance is expected to help ensure that AI models used to support regulatory decision-making are sufficiently credible for the COU.”