Before revision: 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 / 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 and testing of drugs and biologicals to reduce or prevent seriousorlife-threatening conditions caused by exposure to lethal / permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical.