ABSTRACT
In the United States (US), the legal marketing of new animal drugs requires the demonstration of safety, effectiveness, quality manufacturing, and appropriate labeling, culminating in an approval from the US Food and Drug Administration. To begin the new animal drug approval process, a sponsor generally opens an Investigational New Animal Drug file under which data can be submitted. The Target Animal Safety (TAS) technical section includes data, scientific literature, and/or other information that demonstrates the drug is safe for use under the conditions prescribed, recommended, or suggested in proposed labeling in the intended class of animal. The TAS technical section contains any relevant studies or references regarding the safety of humans that administer or may come into direct contact with the new animal drug (user safety). A sponsor is required to demonstrate by substantial evidence that new animal drug has the effect it purports or is represented to have under the proposed conditions of use suggested in the labeling.
