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FDA Press Releases·

FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing

The U.S. Food and Drug Administration today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans.The update reflects advances in science and technology that have expanded the range of testing options available in human drug development, including methods using human cells, organs-on-chips, computer models and other advanced technologies. “This new rule supports the Trump Administration’s push to explore ways to complement, or where appropriate, replace animal studies with methods that may better predict how medicines...