{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.\" This guidance provides a description and basis for a process by which to select a maximum recommended starting dose (MRSD) for a first-in-human clinical trial of a therapeutic in adult healthy volunteers.","action":"Notice.","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/2005/07/22/05-14456.html","cfr_references":[],"citation":"70 FR 42346","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. 2002D-0492"],"dockets":[],"document_number":"05-14456","effective_on":null,"end_page":42346,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/07/22/05-14456.xml","html_url":"https://www.federalregister.gov/documents/2005/07/22/05-14456/guidance-for-industry-on-estimating-the-maximum-safe-starting-dose-in-initial-clinical-trials-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-14456?publication_date=2005-07-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-07-22/05-14456/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":7477,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-07-22/pdf/05-14456.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-07-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/07/22/05-14456.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T16:55:56Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42346,"subtype":null,"title":"Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability","toc_doc":"Initial clinical trials for therapeutics in adult healthy volunteers; maximum safe starting dosage; industry guidance","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":70}