ABSTRACT
Experienced Drug Regulatory Affairs (DRA) personnel are essential in the process of new product development. They are largely responsible for establishing a liaison with their counterparts at the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally. This chapter will center on the regulatory affairs activities in the United States and describe the function and liaison services of the FDA. Emphasis will be on their responsibility for the review and approval of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologic License Applications (BLAs).
