FDA struggles with review of cancer treatments developed with AI

The Food and Drug Administration is struggling to review Moderna and Merck’s mRNA-4157 melanoma cancer vaccine candidate as the companies used artificial intelligence to determine the formulation of the individualized vaccine, Inside Health Policy reported May 8.

FDA biologics chief Peter Marks suggested the agency may not yet be in a position to address whether AI algorithm alterations make a vaccine an entirely new product.

"We have an AI committee that's really trying to think about how we actually...