The Food and Drug Administration has updated its drug and biologic safety regulations to make clear that validated methods using human cells, organs-on-chips, and computer models can be used, where appropriate, to show that a new medicine is reasonably safe before it is first given to people. The agency announced the direct final rule on Sept. 21, and it was scheduled for publication in the Federal Register on Sept. 22.
The rule does not ban animal testing, and it does not change the evidence a drug must provide. What it changes is language in federal regulations that, in some places, suggested animal studies were the only acceptable way to generate safety data.
