The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or 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.
[1] 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.
[2] The FDA can rely on evidence from animal studies to provide substantial evidence of product effectiveness if: FDA published a Guidance for Industry on the Animal Rule in October 2015.
[3]