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
September 11 attacks
September 11 attacks
Animal efficacy rule