The regulations commonly known as the Animal Rule (21 CFR 314.600-650 for drugs; 21 CFR 601.90-95 for biologics; effective July 1, 2002) allow for the approval of drugs and licensure of biological products when human efficacy studies are not ethical and field trials to study the effectiveness of drugs or biological products are not feasible. The use of the Animal Rule is intended for drugs and biological products developed to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances. Under the Animal Rule, efficacy is established based on adequate and well-controlled studies in animal models of the human disease or condition of interest, and safety is evaluated under the preexisting requirements for drugs and biological products. Products approved under the Animal Rule are critical for the protection of public health and national security.
The CDER Drug and Biological Animal Rule Approvals Report provides a detailed list of CDER-regulated products approved under the Animal Rule. CBER-regulated biological products approved under the Animal Rule are also mentioned, in brief, at the end of the table.