{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.\" This guidance is intended to assist sponsors in identifying an optimized dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development prior to submitting an application for approval for a new indication and usage. This guidance does not address selection of the starting dosage for first-in-human trials. In addition, this guidance does not address dosage optimization for radiopharmaceuticals, cellular and gene therapy products, oncolytics, microbiota, or cancer vaccines, nor does it specifically address pediatric drug development. However, some of the principles outlined may be applicable to these therapeutic modalities or to dosage optimization for pediatric patients. This guidance finalizes the draft guidance of the same title \"Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases\" issued on January 23, 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/2024/08/09/2024-17771.html","cfr_references":[],"citation":"89 FR 65366","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on August 9, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2827"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-08-09","updated_at":"2024-09-03T17:18:07.540-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2827-0025","allow_late_comments":false,"id":"FDA-2022-D-2827-0025","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2827","title":"Optimizing the Dosage of Human Prescription Drugs and Biological Products Used in the Treatment of Oncologic Diseases; Draft Guidance for Industry; Availability"}],"document_number":"2024-17771","effective_on":null,"end_page":65368,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/08/09/2024-17771.xml","html_url":"https://www.federalregister.gov/documents/2024/08/09/2024-17771/optimizing-the-dosage-of-human-prescription-drugs-and-biological-products-for-the-treatment-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-17771?publication_date=2024-08-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-08-09/2024-17771/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":612,"last_updated":"2026-10-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-09/pdf/2024-17771.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-17771.pdf?1723121158","publication_date":"2024-08-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/08/09/2024-17771.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-2827","supporting_documents_count":0,"docket_id":"FDA-2022-D-2827","document_id":"FDA-2022-D-2827-0025","regulation_id_number":null,"title":"Optimizing the Dosage of Human Prescription Drugs and Biological Products Used in the Treatment of Oncologic Diseases; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-08-10T15:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65366,"subtype":null,"title":"Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry; Availability","toc_doc":"Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}