Animal Efficacy Rule

The FDA Animal Efficacy Rule (also known as Animal Rule) applies to development and testing of drugs and biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. The animal efficacy rule was finalized by the FDA and authorized by the United States Congress in 2002, following the September 11 attacks and concerns regarding bioterrorism.

The FDA can rely on evidence from animal studies to provide substantial evidence of product effectiveness

FDA published a Guidance for Industry on the Animal Rule in October 2015.

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