ABSTRACT
INTRODUCTION Biologics as a category contain some of the oldest and earliest regulated preventative and therapeutic medicinal products known, as well as the newest and the most novel. The wide array of products regulated as “biologics” has presented regulatory challenges over the years. The Food and Drug Administration (FDA) and its predecessor agencies from time to time have responded to scientific developments by adopting ad hoc approaches to biologics regulation that defy fully coherent and unified explanation. Change within this product category has also caused shifting approaches over the years with respect to the agency component that has chief responsibility for regulating the products, both in terms of which agency within the government and which offices within an agency have principal regulatory responsibility.
