{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Development of Non-Opioid Analgesics for Chronic Pain.\" This guidance is intended to assist sponsors in the development of non- opioid analgesics for the treatment of chronic pain. It describes FDA's current recommendations regarding phase 3 trials for prescription non- opioid analgesic products being developed to treat chronic pain. This guidance also responds to the statutory requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which directs FDA to issue or update existing guidance to help address challenges to developing non- opioid medical products to treat pain.","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/2025/09/11/2025-17442.html","cfr_references":[],"citation":"90 FR 44074","comment_url":null,"comments_close_on":"2025-11-10","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 10, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-0610"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2025-09-11T11:56:36.750-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-0610-0001","allow_late_comments":false,"id":"FDA-2025-D-0610-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-0610","title":"Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability"}],"document_number":"2025-17442","effective_on":null,"end_page":44075,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/09/11/2025-17442.xml","html_url":"https://www.federalregister.gov/documents/2025/09/11/2025-17442/development-of-non-opioid-analgesics-for-chronic-pain-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-17442?publication_date=2025-09-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-09-11/2025-17442/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2397,"last_updated":"2026-07-27 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-11/pdf/2025-17442.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17442.pdf?1757508308","publication_date":"2025-09-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/09/11/2025-17442.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-0610","supporting_documents_count":0,"docket_id":"FDA-2025-D-0610","document_id":"FDA-2025-D-0610-0001","regulation_id_number":null,"title":"Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-09-12T18:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44074,"subtype":null,"title":"Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability","toc_doc":"Development of Non-Opioid Analgesics for Chronic Pain","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}