{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.\" The purpose of this guidance is to inform the public of FDA's application of the abbreviated new drug application (ANDA) approval provisions and 180-day generic drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act (the act) in light of recent court decisions on these issues.","action":"Notice.","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/2000/03/30/00-7823.html","cfr_references":[],"citation":"65 FR 16922","comment_url":null,"comments_close_on":"2000-06-28","correction_of":null,"corrections":[],"dates":"Submit written comments on the guidance by June 28, 2000. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 00D-1197"],"dockets":[],"document_number":"00-7823","effective_on":null,"end_page":16923,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/03/30/00-7823.xml","html_url":"https://www.federalregister.gov/documents/2000/03/30/00-7823/guidance-for-industry-on-court-decisions-anda-approvals-and-180-day-exclusivity-under-the","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-7823?publication_date=2000-03-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-03-30/00-7823/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":71,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-03-30/pdf/00-7823.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-03-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/03/30/00-7823.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16922,"subtype":null,"title":"Guidance for Industry on Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":65}