{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled \"S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.\" The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology-derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The draft guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.","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/2009/02/17/E9-3168.html","cfr_references":[],"citation":"74 FR 7445","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by April 20, 2009.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0006"],"dockets":[],"document_number":"E9-3168","effective_on":null,"end_page":7446,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/02/17/E9-3168.xml","html_url":"https://www.federalregister.gov/documents/2009/02/17/E9-3168/international-conference-on-harmonisation-draft-guidance-on-s9-nonclinical-evaluation-for-anticancer","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-3168?publication_date=2009-02-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-02-17/E9-3168/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":38,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-02-17/pdf/E9-3168.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-02-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/02/17/E9-3168.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-15T14:34:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7445,"subtype":null,"title":"International Conference on Harmonisation; Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability","toc_doc":"Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability","toc_subject":"International Conference on Harmonisation: ","topics":[],"type":"Notice","volume":74}