{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Nonclinical Safety Evaluation of Drug Combinations.\" The guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), copackaged products, and adjunctive therapies.","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/2005/01/26/05-1394.html","cfr_references":[],"citation":"70 FR 3714","comment_url":null,"comments_close_on":"2005-04-26","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidance by April 26, 2005. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 2005D-0004"],"dockets":[],"document_number":"05-1394","effective_on":null,"end_page":3715,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/01/26/05-1394.xml","html_url":"https://www.federalregister.gov/documents/2005/01/26/05-1394/draft-guidance-for-industry-on-nonclinical-safety-evaluation-of-drug-combinations-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-1394?publication_date=2005-01-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-01-26/05-1394/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":57,"last_updated":"2026-10-22 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-01-26/pdf/05-1394.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-01-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/01/26/05-1394.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T15:10:49Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3714,"subtype":null,"title":"Draft Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations; Availability","toc_doc":"Drug combinations; nonclinical safety evalution","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":70}