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FDA replaces animal testing terms in new drug safety rule

9/23/2026

The federal government has updated its drug approval rules to allow human-based research methods to replace animal testing in many cases.

This is the second major push by the Department of Health and Human Services this year to shift medical science away from animal models.

The core change is a final rule from the Food and Drug Administration that redefines how safety data is collected for new drugs and biologics. The rule does not ban animal testing outright.

Instead, it states that other research methods can be used when appropriate for determining safety. The most visible part of the change is linguistic.

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