{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Nonclinical Safety Evaluation of Drug or Biologic Combinations.\" This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), co-packaged products, and some 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/2006/03/15/E6-3713.html","cfr_references":[],"citation":"71 FR 13410","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. 2005D-0004"],"dockets":[],"document_number":"E6-3713","effective_on":null,"end_page":13411,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2006/03/15/E6-3713.xml","html_url":"https://www.federalregister.gov/documents/2006/03/15/E6-3713/guidance-for-industry-on-nonclinical-safety-evaluation-of-drug-or-biologic-combinations-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E6-3713?publication_date=2006-03-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2006-03-15/E6-3713/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":451,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2006-03-15/pdf/E6-3713.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2006-03-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2006/03/15/E6-3713.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T18:53:44Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13410,"subtype":null,"title":"Guidance for Industry on Nonclinical Safety Evaluation of Drug or Biologic Combinations; Availability","toc_doc":"Drug or biologic combinations; nonclinical safety evaluation; industry guidance","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":71}