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GUIDANCE DOCUMENT

Clinical Pharmacology Considerations for Peptide Drug Products December 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 2 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-3391
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-3391.

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