{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.\" This guidance provides recommendations to industry for establishing the clinical effectiveness of drugs for the treatment of acne vulgaris (acne). This guidance finalizes the draft guidance for industry entitled \"Acne Vulgaris: Developing Drugs for Treatment,\" issued September 19, 2005.","action":"Notice of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/2018/05/22/2018-10928.html","cfr_references":[],"citation":"83 FR 23689","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 22, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2005-D-0461"],"dockets":[],"document_number":"2018-10928","effective_on":null,"end_page":23690,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/05/22/2018-10928.xml","html_url":"https://www.federalregister.gov/documents/2018/05/22/2018-10928/acne-vulgaris-establishing-effectiveness-of-drugs-intended-for-treatment-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-10928?publication_date=2018-05-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-05-22/2018-10928/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":539,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-05-22/pdf/2018-10928.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-10928.pdf?1526906734","publication_date":"2018-05-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/05/22/2018-10928.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Guidance","document_id":"FDA-2005-D-0461-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2005-D-0461","supporting_documents_count":1,"docket_id":"FDA-2005-D-0461","regulation_id_number":null,"title":"Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment","checked_regulationsdotgov_at":"2018-06-11T10:00:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23689,"subtype":null,"title":"Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for Industry; Availability","toc_doc":"Acne Vulgaris:  Establishing Effectiveness of Drugs Intended for Treatment","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}