FDA proposing pathway to cut time to first-in-human trials

FDA is planning a new pathway that could sharply reduce the cost and time required to launch first-in-human studies by allowing validated non-animal methods to substitute for some traditional animal testing.

In contrast to countries that have put tight timelines in place to speed reviews of FIH trials, the U.S. is considering fundamental changes in the type of evidence required to approve trial starts. The new pathway would allow sponsors to meet the regulatory requirements for launching a Phase I trial with validated new approach methods (NAMs), in place of certain traditional animal toxicology data...