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# Comments Sought Peptide Clin/Pharm Evaluations
- URL: https://www.fdaweb.com/comments-sought-peptide-clin-pharm-evaluations/
- Published: 2021-05-14T12:00:00.000Z
- Updated: 2026-09-14T16:59:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149321

*Federal Register* notice: FDA has opened a public docket for comments on “Evaluating the Clinical Pharmacology of Peptides.” The agency is seeking comments on the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides as well as the effects of peptides on cardiac electrophysiology. Although FDA has been regulating peptides for decades, there is a desire for specific considerations on the design and conduct of clinical pharmacology studies to assess peptides, such as those designed to evaluate the effects of organ impairment or drug interactions. Currently, there are no FDA published guidance documents on clinical pharmacology assessments that contain specific recommendations for peptides. Public comments will help FDA develop recommendations for designing and conducting studies important to the safe and effective use of peptides and help with regulatory assessments of such studies. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-05-14/pdf/2021-10179.pdf?ref=fdaweb.com).