{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.\" The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of early Lyme disease as manifested by erythema migrans (EM). This guidance finalizes the draft guidance of the same name issued on February 1, 2023.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2025/06/26/2025-11809.html","cfr_references":[],"citation":"90 FR 27320","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on June 26, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2315"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-06-26","updated_at":"2025-06-26T09:57:34.443-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2315-0011","allow_late_comments":false,"id":"FDA-2022-D-2315-0011","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2315","title":"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2025-11809","effective_on":null,"end_page":27321,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/06/26/2025-11809.xml","html_url":"https://www.federalregister.gov/documents/2025/06/26/2025-11809/early-lyme-disease-as-manifested-by-erythema-migrans-developing-drugs-for-treatment-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-11809?publication_date=2025-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-06-26/2025-11809/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":143,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-26/pdf/2025-11809.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11809.pdf?1750855520","publication_date":"2025-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/06/26/2025-11809.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-2022-D-2315","supporting_documents_count":0,"docket_id":"FDA-2022-D-2315","document_id":"FDA-2022-D-2315-0011","regulation_id_number":null,"title":"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-06-27T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27320,"subtype":null,"title":"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment; Guidance for Industry; Availability","toc_doc":"Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}