Source: Veterinary Practice News
The U.S. Food and Drug Administration has updated regulations to clarify that non-animal testing methods may be used when appropriate to evaluate the safety of drugs and biological products before human clinical trials.
The direct final rule recognizes advances in New Approach Methodologies, including human cell-based systems, organ-on-chip technologies, computer modeling, and other methods designed to reflect human biology. Regulatory terminology will also shift from “animal tests” and “animal studies” to “nonclinical tests” and “nonclinical studies.”
The FDA emphasized that the rule does not prohibit animal studies, change evidentiary standards, or require developers to use non-animal alternatives. Instead, validated methods can be selected based on scientific and regulatory needs.
The agency also introduced a database containing 25 examples showing how New Approach Methodologies have been used in regulatory settings. The FDA says recognizing these approaches could provide developers with greater regulatory clarity while advancing innovative testing methods and potentially reducing reliance on animals.