Chapter 1. Regulatory Considerations for Peptide Therapeutics

Abstract

The increasing interest of the pharmaceutical industry in peptide therapeutics has been a catalyst for the development of regulations in this area. Nevertheless, manufacturers and regulators continue to encounter scientific and regulatory challenges when dealing with peptides as active pharmaceutical ingredients in drug products. This chapter presents an up-to-date overview of the approval process for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) as it pertains to peptide drugs at the US Food and Drug Administration (FDA). It also provides a structured summary of the quality considerations relevant to peptides. This includes unique characteristics concerning structurecharacterization, manufacturing, and impurities emerging from the manufacturing process or storage and their potential impact on peptide drug safety and efficacy.