{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.\" This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.","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/2018/12/04/2018-26333.html","cfr_references":[],"citation":"83 FR 62582","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-3632-0001","comments_close_on":"2019-02-04","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 4, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2018-D-3632"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":11,"comment_start_date":"2018-12-04","updated_at":"2024-11-13T13:18:30.115-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-3632-0001","allow_late_comments":true,"id":"FDA-2018-D-3632-0001","comment_end_date":"2019-02-05","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-3632","title":"Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability "}],"document_number":"2018-26333","effective_on":null,"end_page":62583,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/04/2018-26333.xml","html_url":"https://www.federalregister.gov/documents/2018/12/04/2018-26333/noncirrhotic-nonalcoholic-steatohepatitis-with-liver-fibrosis-developing-drugs-for-treatment-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-26333?publication_date=2018-12-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-04/2018-26333/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1181,"last_updated":"2026-06-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-04/pdf/2018-26333.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-26333.pdf?1543844736","publication_date":"2018-12-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/04/2018-26333.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":11,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-3632","supporting_documents_count":0,"docket_id":"FDA-2018-D-3632","document_id":"FDA-2018-D-3632-0001","regulation_id_number":null,"title":"Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2024-11-13T21:55:09Z"},"regulations_dot_gov_url":"https://www.regulations.gov/commenton/FDA-2018-D-3632-0001","significant":null,"signing_date":null,"start_page":62582,"subtype":null,"title":"Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis:  Developing Drugs for Treatment","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}