{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.\" This draft guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed-combination drug products (fixed combinations). If the guidance is finalized, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of \"new chemical entity,\" regardless of whether that drug substance is approved alone or in certain fixed-combinations.","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/2014/02/24/2014-03885.html","cfr_references":[],"citation":"79 FR 10167","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 25, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1675"],"dockets":[],"document_number":"2014-03885","effective_on":null,"end_page":10168,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/02/24/2014-03885.xml","html_url":"https://www.federalregister.gov/documents/2014/02/24/2014-03885/draft-guidance-for-industry-on-new-chemical-entity-exclusivity-determinations-for-certain","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-03885?publication_date=2014-02-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-02-24/2014-03885/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1039,"last_updated":"2026-08-24 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-02-24/pdf/2014-03885.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-03885.pdf?1392990626","publication_date":"2014-02-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/02/24/2014-03885.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-03-21T05:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10167,"subtype":null,"title":"Draft Guidance for Industry on New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products; Availability","toc_doc":"New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products; Availability","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":79}