Clinical pharmacology - navigation tools for a world filled with generic options

Abstract

Understanding the basic types of drug product approval appli­cations can be helpful when selecting products to recommend for use within a particular livestock system. Products that do not have an NADA or ANADA number have not been through any type of FDA approval process. Products with an ANADA, commonly referred to as “generics”, have an abbreviated ap­proval process through the FDA. Many products necessary for daily practice are listed in the FDA’s Green Book. This document gives several examples of specific approval types, and how that relates to the effectiveness evidence for the product in the bottle. Both a solid understanding of the effectiveness evidence generated by the approval process, as well as the context within which the product will be used is necessary to make recom­mendations for use of these products within livestock systems.