{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Clinical Pharmacology Considerations for Peptide Drug Products.\" This guidance describes FDA's recommendations regarding clinical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 The intent of this draft guidance, when finalized, is to assist industry in the conduct of these development programs.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/09/11/2023-19456.html","cfr_references":[],"citation":"88 FR 62378","comment_url":null,"comments_close_on":"2023-12-11","correction_of":null,"corrections":[],"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either electronic or written comments on the draft guidance by December 11, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-3391"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-09-11","updated_at":"2023-09-11T12:56:02.842-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-3391-0002","allow_late_comments":null,"id":"FDA-2023-D-3391-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-3391","title":"Clinical Pharmacology Considerations for Peptide Drug Products; Draft Guidance for Industry; Availability"}],"document_number":"2023-19456","effective_on":null,"end_page":62379,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/09/11/2023-19456.xml","html_url":"https://www.federalregister.gov/documents/2023/09/11/2023-19456/clinical-pharmacology-considerations-for-peptide-drug-products-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-19456?publication_date=2023-09-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-09-11/2023-19456/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1247,"last_updated":"2026-09-21 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-11/pdf/2023-19456.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-19456.pdf?1694177179","publication_date":"2023-09-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/09/11/2023-19456.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-D-3391","supporting_documents_count":0,"docket_id":"FDA-2023-D-3391","document_id":"FDA-2023-D-3391-0002","regulation_id_number":null,"title":"Clinical Pharmacology Considerations for Peptide Drug Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-09-12T15:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":62378,"subtype":null,"title":"Clinical Pharmacology Considerations for Peptide Drug Products; Draft Guidance for Industry; Availability","toc_doc":"Clinical Pharmacology Considerations for Peptide Drug Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}