An overview of the regulatory approval process in drug development

This paper provides a brief history and an overview of the regulatory process for drug approval in the United States through illustrations of Investigational New Drug (INDs) Applications and New Drug Applications (NDAs). For INDs, the regulatory requirements for a well-designed protocol, the role and responsibility of institutional review boards, and the applicability of treatment INDs are discussed. For NDAs, issues regarding the application of expanded access, the submission of abbreviated NDAs for a generic drug, the submission of supplemental NDAs for labeling changes, and the role and responsibility of advisory committees are addressed.

Duke Scholars

Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics