The Food and Drug Administration has issued a rule that rewrites parts of its drug regulations so that non-animal methods, such as human cell tests, organ chips, and computer models, can be used where appropriate to show a medicine is safe enough to test in people. The agency announced the change Sept. 21, and it was published in the Federal Register the next day. The rule does not ban animal studies, and it does not lower the safety bar a drug must clear before human trials.
The update is technical but meaningful. Many FDA rules previously referred specifically to animal tests, which could suggest animals were the only accepted source of early safety data. The new wording treats animal studies as one option among several.
