FDA issues rule to allow non-animal testing methods for drug safety
FDA issued a direct final rule that updates its regulations to clarify that non-animal methods may be used for safety testing of drugs and biological products before they are tested in humans.
The rule reflects advances such as human cell cultures, organs-on-chips, computer models and other advanced technologies, giving scientists and developers more flexibility to choose the approach that best answers their scientific questions.
The agency emphasizes that the change is not intended to replace animal studies entirely, but to support rigorous modern science, replacing terms like "animal tests" with "nonclinical tests" and updating related terminology.
This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing”
read at fda press ↗
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