Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Considerations for Peptide Drug Products." This guidance describes FDA's recommendations regarding clinical pharmacology considerations for peptide drug product development programs, including hepatic impairment, drug-drug interactions (DDIs), assessing QTc prolongation risk, and immunogenicity risk and impact on the pharmacokinetics (PK), safety, and efficacy assessment. The intent of this draft guidance, when finalized, is to assist industry in the conduct of these development programs.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-D-3391] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Clinical Pharmacology Considerations for Peptide Drug Products.” This guidance describes FDA's recommendations regarding clinical pharmacology considerations for peptide drug product development programs, including hepatic impairment, drug-drug interactions (DDIs), assessing QTc prolongation risk, and immunogenicity risk and impact on the pharmacokinetics (PK), safety, and efficacy assessment. The intent of this draft guidance, when finalized, is to assist industry in the conduct of these development programs. DATES: Submit either electronic or written comments on the draft guidance by December 11, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely …
Citation: 88 FR 62378
