{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Malaria: Developing Drugs for Treatment.\" The purpose of this draft guidance is to assist sponsors in the overall development program for drug and biological products for the treatment of malaria, caused by clinically relevant Plasmodium species.","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/2025/09/23/2025-18407.html","cfr_references":[],"citation":"90 FR 45773","comment_url":null,"comments_close_on":"2025-12-22","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 22, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2025-D-0918"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-09-23","updated_at":"2025-09-23T10:02:30.091-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-0918-0001","allow_late_comments":false,"id":"FDA-2025-D-0918-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-0918","title":"Malaria:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2025-18407","effective_on":null,"end_page":45774,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/09/23/2025-18407.xml","html_url":"https://www.federalregister.gov/documents/2025/09/23/2025-18407/malaria-developing-drugs-for-treatment-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-18407?publication_date=2025-09-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-09-23/2025-18407/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":243,"last_updated":"2026-06-24 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-23/pdf/2025-18407.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18407.pdf?1758545116","publication_date":"2025-09-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/09/23/2025-18407.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-2025-D-0918","supporting_documents_count":0,"docket_id":"FDA-2025-D-0918","document_id":"FDA-2025-D-0918-0001","regulation_id_number":null,"title":"Malaria:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-09-24T16:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45773,"subtype":null,"title":"Malaria: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Malaria: Developing Drugs for Treatment","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}