{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Determining Whether to Submit an ANDA or a 505(b)(2) Application.\" This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. The guidance announced in this notice finalizes the draft guidance with the same name dated October 2017.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and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/2019/05/10/2019-09662.html","cfr_references":[],"citation":"84 FR 20637","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 10, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-5974"],"dockets":[],"document_number":"2019-09662","effective_on":null,"end_page":20638,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/05/10/2019-09662.xml","html_url":"https://www.federalregister.gov/documents/2019/05/10/2019-09662/determining-whether-to-submit-an-abbreviated-new-drug-application-or-a-505b2-application-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-09662?publication_date=2019-05-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-05-10/2019-09662/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1266,"last_updated":"2026-07-26 08:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-05-10/pdf/2019-09662.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-09662.pdf?1557405919","publication_date":"2019-05-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/05/10/2019-09662.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-2017-D-5974","supporting_documents_count":0,"docket_id":"FDA-2017-D-5974","regulation_id_number":null,"title":"Determining Whether to Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2019-05-23T10:01:56Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20637,"subtype":null,"title":"Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application; Guidance for Industry; Availability","toc_doc":"Determining Whether to Submit an Abbreviated New Drug Application or a 505(b)(2) Application","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}