{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.\" This draft guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable 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/2024/07/23/2024-16128.html","cfr_references":[],"citation":"89 FR 59740","comment_url":null,"comments_close_on":"2024-09-23","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 23, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-2581"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-07-23T10:56:23.362-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2581-0001","allow_late_comments":null,"id":"FDA-2024-D-2581-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2581","title":"Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products:  Questions and Answers; Draft Guidance for Industry; Availability"}],"document_number":"2024-16128","effective_on":null,"end_page":59742,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/07/23/2024-16128.xml","html_url":"https://www.federalregister.gov/documents/2024/07/23/2024-16128/postapproval-manufacturing-changes-to-biosimilar-and-interchangeable-biosimilar-products-questions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-16128?publication_date=2024-07-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-07-23/2024-16128/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":366,"last_updated":"2026-08-24 22:15:11 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-23/pdf/2024-16128.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16128.pdf?1721652324","publication_date":"2024-07-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/07/23/2024-16128.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-D-2581","supporting_documents_count":0,"docket_id":"FDA-2024-D-2581","document_id":"FDA-2024-D-2581-0001","regulation_id_number":null,"title":"Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products:  Questions and Answers; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-07-24T13:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59740,"subtype":null,"title":"Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability","toc_doc":"Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}