FDA News: Issue 12, May 2021

Author: [AUTHOR] Published on 5/18/2021 8:02:00 AM

FDA Announces Availability of a Federal Register Notice on Evaluating the Clinical Pharmacology of Peptides

On May 14, 2021, the US Food and Drug Administration (FDA) announced the availability of a Federal Register notice titled “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.

FDA uses the term “peptide” to refer to polymers composed of 40 or fewer amino acids. Peptides can be isolated from whole animal tissue, or produced in vitro, synthetically, or through recombinant expression, and often serve as signaling molecules for many physiologic functions that are regulated by endogenous proteins. Peptides can exhibit distinct combinations of characteristics regarding their chemistry, pharmacology, sites of action, pharmacokinetic disposition, and pharmacodynamics.

Although 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 guidance documents on clinical pharmacology assessments that contain specific recommendations for peptides. Public comments will help FDA develop recommendations for the design and conduct of studies important to the safe and effective use of peptides and facilitate the regulatory assessment of such studies.

The Federal Register Notice “Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Comments” is available at https://www.federalregister.gov. Please refer to this notice for more details. You may submit your comments regarding the notice to the docket (Docket No. FDA-2021-N-0347) available at https://www.regulations.gov up to 60 days following publication in the FEDERAL REGISTER. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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