{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.\" This guidance is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 the optimal 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 nor does it address dosage optimization for radiopharmaceuticals, cellular and gene therapy products, microbiota, or cancer vaccines.","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/2023/01/18/2023-00837.html","cfr_references":[],"citation":"88 FR 2932","comment_url":null,"comments_close_on":"2023-03-20","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 20, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2022-D-2827"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-01-18","updated_at":"2023-02-24T18:29:50.271-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2827-0001","allow_late_comments":null,"id":"FDA-2022-D-2827-0001","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":"2023-00837","effective_on":null,"end_page":2933,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/01/18/2023-00837.xml","html_url":"https://www.federalregister.gov/documents/2023/01/18/2023-00837/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/2023-00837?publication_date=2023-01-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-01-18/2023-00837/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1304,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-01-18/pdf/2023-00837.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-00837.pdf?1673963137","publication_date":"2023-01-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/01/18/2023-00837.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-2827-0001","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":"2023-03-01T19:45:37Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2932,"subtype":null,"title":"Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Draft 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":88}