What is meant by “Required Under: Animal Efficacy Rule” in the search results display?
On May 31, 2002, FDA published the final rule to allow use of animal data for evidence of the drug’s effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans. In these situations, certain new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances may be approved for marketing based on evidence of effectiveness derived from appropriate studies in animals and any additional supporting data. Under this rule, the applicant must conduct postmarket studies or clinical trials to verify and describe the drug’s clinical benefit when such studies or clinical trials are feasible and ethical. Such postmarket studies or clinical trials may not be feasible until an exigency arises that necessitates use of the product.
