{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.\" This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.","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/2013/04/01/2013-07445.html","cfr_references":[],"citation":"78 FR 19492","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 31, 2013. Submit either electronic or written comments concerning the proposed collection of information by May 31, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0286"],"dockets":[],"document_number":"2013-07445","effective_on":null,"end_page":19495,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/04/01/2013-07445.xml","html_url":"https://www.federalregister.gov/documents/2013/04/01/2013-07445/draft-guidance-for-industry-on-formal-meetings-between-fda-and-biosimilar-biological-product","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-07445?publication_date=2013-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-04-01/2013-07445/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1262,"last_updated":"2026-04-05 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-04-01/pdf/2013-07445.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-07445.pdf?1364561362","publication_date":"2013-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/04/01/2013-07445.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0286","supporting_documents_count":null,"docket_id":"FDA-2013-D-0286","regulation_id_number":null,"title":"Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants","checked_regulationsdotgov_at":"2013-05-26T05:00:46Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19492,"subtype":null,"title":"Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants; Availability","toc_doc":"Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}