Before 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.
After revision: The FDA Animal Efficacy Rule (also known as Animal Rule) applies to developmentandtesting 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.