{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.\" This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II).","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/2017/10/03/2017-21190.html","cfr_references":[],"citation":"82 FR 46071","comment_url":null,"comments_close_on":"2017-12-04","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2017-D-5739"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2017-10-03","updated_at":"2023-02-28T21:37:02.260-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-5739-0001","allow_late_comments":null,"id":"FDA-2017-D-5739-0001","comment_end_date":"2017-12-05","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-D-5739","title":"Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA; Draft Guidance for Industry; Availability "}],"document_number":"2017-21190","effective_on":null,"end_page":46072,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/10/03/2017-21190.xml","html_url":"https://www.federalregister.gov/documents/2017/10/03/2017-21190/formal-meetings-between-the-food-and-drug-administration-and-abbreviated-new-drug-application","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-21190?publication_date=2017-10-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-10-03/2017-21190/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1207,"last_updated":"2026-07-28 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/2017-21190.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-21190.pdf?1506948350","publication_date":"2017-10-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/10/03/2017-21190.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-D-5739","supporting_documents_count":0,"docket_id":"FDA-2017-D-5739","document_id":"FDA-2017-D-5739-0001","regulation_id_number":null,"title":"Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-03-01T02:37:01Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46071,"subtype":null,"title":"Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability","toc_doc":"Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}