FDA Issues Federal Register Notice on Evaluating the Clinical Pharmacology of Peptides Today, the Food and Drug Administration issued a Federal Register notice, "Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Comments." This notice establishes a public docket to collect comments on evaluating the clinical pharmacology of peptides, including but not limited to, 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 the FDA has been regulating peptides for decades, there is a growing appreciation for specific considerations for 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 guidances on clinical pharmacology assessments that contain specific recommendations for peptides. Public comments will help the FDA develop recommendations for the design and conduct of studies important to the safe and effective use of peptides and to facilitate the regulatory assessment of such studies. The "Evaluating the Clinical Pharmacology of Peptides; Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Comments" Federal Register notice is available at https://www.federalregister.gov. You may submit your comments regarding the notice to the public docket (Docket No. FDA-2021-N-0347) available at https://www.regulations.gov up to 60 days following publication in the Federal Register. | 
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