ABSTRACT
With the threats of global infectious disease outbreak and biological weapon terrorism, development of biologics to prevent and treat pathogens requires innovation, production speed, and capacity. The technology needed to monitor and respond to these threats is highly sophisticated and still evolving both in capability and reliability. Advances in biotechnology have resulted in novel vaccines to accelerate production or improve immunogenicity (Table 13.1).1 The use of biologics to treat noninfectious disease is also expanding, with applications in such areas as oncology and inflammation. In this chapter, we will review regulatory oversight of biologics by the Food and Drug Administration (FDA) from design, through development and licensure, and provide an overview of the regulatory processes that govern biologics entry to interstate commerce in the United States.
