Before revision: The FDA Animal Efficacy Rule ( finalized May 2002 ) applies to development/testing of drugs / biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal /permanently disabling toxic agent (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical.
After revision: The FDA Animal Efficacy Rule ( also known as Animal Rule ) applies to development/testing of drugs / biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal /permanently disabling toxic agent (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical.