{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.\" This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter.","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/2019/02/01/2019-00569.html","cfr_references":[],"citation":"84 FR 1152","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on February 1, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-2561"],"dockets":[],"document_number":"2019-00569","effective_on":null,"end_page":1153,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/02/01/2019-00569.xml","html_url":"https://www.federalregister.gov/documents/2019/02/01/2019-00569/coordinated-development-of-antimicrobial-drugs-and-antimicrobial-susceptibility-test-devices","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-00569?publication_date=2019-02-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-02-01/2019-00569/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":388,"last_updated":"2026-10-24 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-02-01/pdf/2019-00569.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-00569.pdf?1548942322","publication_date":"2019-02-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/02/01/2019-00569.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-2561","supporting_documents_count":0,"docket_id":"FDA-2016-D-2561","regulation_id_number":null,"title":"Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2019-02-21T11:00:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":1152,"subtype":null,"title":"Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}