{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a points to consider (PTC) document entitled ``Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997).'' This PTC document is intended to assist sponsors and investigators engaged in monoclonal antibody product development and it includes information to submit when filing investigational new drug applications and product license applications. The document revises a 1994 document entitled ``Draft Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.''","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1997/02/28/97-5006.html","cfr_references":[],"citation":"62 FR 9196","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Written comments may be submitted at any time.","disposition_notes":null,"docket_ids":["Docket No. 94D-0259"],"dockets":[],"document_number":"97-5006","effective_on":null,"end_page":9197,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/02/28/97-5006/points-to-consider-in-the-manufacture-and-testing-of-monoclonal-antibody-products-for-human-use-1997","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-5006?publication_date=1997-02-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-02-28/97-5006/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1004,"last_updated":"2026-07-26 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-02-28/pdf/97-5006.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-02-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/02/28/97-5006.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T00:56:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9196,"subtype":null,"title":"``Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997);'' Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":62}