{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.\" This guidance describes FDA's current recommendations about endotoxin limits in certain investigational oncology drugs and biological products. This guidance looks at a risk- based approach of weighing the potential risks of not evaluating endotoxin levels in all components of a multidrug regimen against the potential benefits to patients with serious and life-threatening diseases.","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/2020/07/29/2020-16340.html","cfr_references":[],"citation":"85 FR 45643","comment_url":null,"comments_close_on":"2020-09-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 28, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2020-D-1294"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":7,"comment_start_date":"2020-07-29","updated_at":"2023-02-28T22:52:08.762-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-1294-0001","allow_late_comments":null,"id":"FDA-2020-D-1294-0001","comment_end_date":"2020-09-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-1294","title":"Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products; Draft Guidance for Industry; Availability "}],"document_number":"2020-16340","effective_on":null,"end_page":45644,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/29/2020-16340.xml","html_url":"https://www.federalregister.gov/documents/2020/07/29/2020-16340/setting-endotoxin-limits-during-development-of-investigational-oncology-drugs-and-biological","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-16340?publication_date=2020-07-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-29/2020-16340/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1812,"last_updated":"2026-09-21 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-29/pdf/2020-16340.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-16340.pdf?1595940318","publication_date":"2020-07-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/29/2020-16340.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":7,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-D-1294","supporting_documents_count":0,"docket_id":"FDA-2020-D-1294","document_id":"FDA-2020-D-1294-0001","regulation_id_number":null,"title":"Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-03-01T03:52:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45643,"subtype":null,"title":"Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products; Draft Guidance for Industry; Availability","toc_doc":"Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":85}