{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Endogenous Cushing's Syndrome: Developing Drugs for Treatment.\" The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial designs for drugs intended for the treatment of adults with endogenous Cushing's syndrome for whom surgery is not an option or has not been curative. This draft guidance is intended to focus continued discussions among FDA's Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.","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/2023/09/08/2023-19419.html","cfr_references":[],"citation":"88 FR 62090","comment_url":null,"comments_close_on":"2023-11-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 7, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2023-D-3518"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-09-08T10:56:55.925-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-3518-0001","allow_late_comments":null,"id":"FDA-2023-D-3518-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-3518","title":"Endogenous Cushing’s Syndrome: Developing Drugs for Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2023-19419","effective_on":null,"end_page":62091,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/09/08/2023-19419.xml","html_url":"https://www.federalregister.gov/documents/2023/09/08/2023-19419/endogenous-cushings-syndrome-developing-drugs-for-treatment-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-19419?publication_date=2023-09-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-09-08/2023-19419/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":271,"last_updated":"2026-10-24 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-08/pdf/2023-19419.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-19419.pdf?1694090787","publication_date":"2023-09-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/09/08/2023-19419.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-2023-D-3518","supporting_documents_count":0,"docket_id":"FDA-2023-D-3518","document_id":"FDA-2023-D-3518-0001","regulation_id_number":null,"title":"Endogenous Cushing’s Syndrome: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-09-10T01:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":62090,"subtype":null,"title":"Endogenous Cushing's Syndrome: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Endogenous Cushing's Syndrome: Developing Drugs for Treatment","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}