{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Labeling for Biosimilar Products.\" This draft guidance is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert). This draft guidance provides an overview of FDA's recommendations for labeling for biosimilar products licensed under the Public Health Service Act (PHS Act).","action":"Notice of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/2016/04/04/2016-07611.html","cfr_references":[],"citation":"81 FR 19194","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-0643"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":30,"comment_start_date":"2016-04-04","updated_at":"2023-09-18T09:56:12.764-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-D-0643-0001","allow_late_comments":null,"id":"FDA-2016-D-0643-0001","comment_end_date":"2016-06-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2016-D-0643","title":"Labeling for Biosimilar Products"}],"document_number":"2016-07611","effective_on":null,"end_page":19195,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/04/04/2016-07611.xml","html_url":"https://www.federalregister.gov/documents/2016/04/04/2016-07611/labeling-for-biosimilar-products-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-07611?publication_date=2016-04-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-04-04/2016-07611/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":991,"last_updated":"2026-08-25 04:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-04-04/pdf/2016-07611.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-07611.pdf?1459514864","publication_date":"2016-04-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/04/04/2016-07611.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":30,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-0643","supporting_documents_count":0,"docket_id":"FDA-2016-D-0643","document_id":"FDA-2016-D-0643-0001","regulation_id_number":null,"title":"Labeling for Biosimilar Products","checked_regulationsdotgov_at":"2023-09-19T13:00:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19194,"subtype":null,"title":"Labeling for Biosimilar Products; Draft Guidance for Industry; Availability","toc_doc":"Labeling for Biosimilar Products","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}