{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Orange Book--Questions and Answers.\" This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This guidance finalizes the draft guidance of the same title issued on June 1, 2020.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health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/2022/07/25/2022-15831.html","cfr_references":[],"citation":"87 FR 44125","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 25, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-1068"],"dockets":[{"supporting_documents":[{"title":"Orange Book Questions and Answers Guidance for Industry - Draft","document_id":"FDA-2020-D-1068-0006"},{"title":"Orange Book—Questions and Answers; Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0005"},{"title":"Orange Book Questions and Answers; Guidance for Industry; Draft Guidance","document_id":"FDA-2020-D-1068-0002"},{"title":"Orange Book—Questions and Answers; Draft Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-07-25","updated_at":"2023-02-27T19:32:29.400-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-1068-0005","allow_late_comments":null,"id":"FDA-2020-D-1068-0005","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2020-D-1068","title":"Orange Book – Questions and Answers; Draft Guidance for Industry; Availability"}],"document_number":"2022-15831","effective_on":null,"end_page":44126,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/07/25/2022-15831.xml","html_url":"https://www.federalregister.gov/documents/2022/07/25/2022-15831/orange-book-questions-and-answers-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-15831?publication_date=2022-07-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-07-25/2022-15831/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":680,"last_updated":"2026-10-24 00:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-07-25/pdf/2022-15831.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-15831.pdf?1658493926","publication_date":"2022-07-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/07/25/2022-15831.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Orange Book Questions and Answers Guidance for Industry - Draft","document_id":"FDA-2020-D-1068-0006"},{"title":"Orange Book—Questions and Answers; Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0005"},{"title":"Orange Book Questions and Answers; Guidance for Industry; Draft Guidance","document_id":"FDA-2020-D-1068-0002"},{"title":"Orange Book—Questions and Answers; Draft Guidance for Industry; Availability","document_id":"FDA-2020-D-1068-0001"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-D-1068","supporting_documents_count":4,"docket_id":"FDA-2020-D-1068","document_id":"FDA-2020-D-1068-0005","regulation_id_number":null,"title":"Orange Book – Questions and Answers; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-02-28T00:32:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44125,"subtype":null,"title":"Orange Book-Questions and Answers; Guidance for Industry; Availability","toc_doc":"Orange BookQuestions and Answers","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}