This guidance provides recommendations to assist industry in the development of peptide drug products. Specifically, this guidance, when finalized, will describe the FDA’s current thinking regarding the impact of clinical pharmacology considerations, including hepatic impairment, drug-drug interactions (DDIs), QTc prolongation risk, and immunogenicity risk on a peptide drug product’s pharmacokinetics (PK), safety, and efficacy.

This guidance specifically outlines clinical pharmacology considerations for development programs for proposed peptide drug products submitted in a new drug application (NDA) under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and references other relevant guidances when appropriate.