Environmental considerations for minor use animal drugs

This presentation outlines the basis for the FDA requirement that environmental considerations, via an environmental document, be included for evaluation as part of the application for animal drugs. Next, the environmental document for an animal drug application and three important types of environmental information that need to be included in the environmental document are discussed. The abbreviated environmental information requirements for some minor use applications are presented. Finally, 2 points presented previously by Dr Katz on the preparation of environmental documents for minor use animal drugs are clarified.