chapter  15
30 Pages

Obtaining Approval of a Generic Drug, Pre-1984 to the Present

WithLoren Gelber

INTRODUCTION In order to obtain approval of a generic drug product, a sponsor must submit an abbreviated new drug application (ANDA) to the FDA’s Center for Drug Evaluation and Research (CDER) Office of Generic Drugs (OGD). The sponsor can be a drug company that intends to manufacture the generic drug itself and has performed the necessary research to obtain the data required for submission, which will be described in this chapter. Alternatively, the sponsor could be some individual or group that has done the research or obtained the rights to the research performed by others, even if the sponsor does not intend to manufacture the product itself. For simplicity in this chapter, we will refer to the sponsor as the applicant.