{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Major Depressive Disorder: Developing Drugs for Treatment.\" The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder (MDD). Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This draft guidance revises the guidance for industry entitled \"Guidelines for the Clinical Evaluation of Antidepressant Drugs\" issued in September 1977.","action":"Notice of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/2018/06/21/2018-13297.html","cfr_references":[],"citation":"83 FR 28851","comment_url":null,"comments_close_on":"2018-08-20","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-1919"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":6,"comment_start_date":"2018-06-21","updated_at":"2023-03-01T01:37:15.395-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1919-0001","allow_late_comments":null,"id":"FDA-2018-D-1919-0001","comment_end_date":"2018-08-21","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1919","title":"Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2018-13297","effective_on":null,"end_page":28853,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/21/2018-13297.xml","html_url":"https://www.federalregister.gov/documents/2018/06/21/2018-13297/major-depressive-disorder-developing-drugs-for-treatment-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-13297?publication_date=2018-06-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-21/2018-13297/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1056,"last_updated":"2026-10-25 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-21/pdf/2018-13297.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-13297.pdf?1529498719","publication_date":"2018-06-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/21/2018-13297.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1919","supporting_documents_count":0,"docket_id":"FDA-2018-D-1919","document_id":"FDA-2018-D-1919-0001","regulation_id_number":null,"title":"Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T06:37:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28851,"subtype":null,"title":"Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Major Depressive Disorder: Developing Drugs for Treatment","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}