{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Qualification of Biomarker--Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease.\" This draft guidance provides a qualified context of use (COU) for plasma fibrinogen in interventional clinical trials of chronic obstructive pulmonary disease (COPD) subjects at high risk for exacerbations and/or all-cause mortality. This draft guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker. In the Federal Register of January 7, 2014, FDA announced the availability of a final guidance for industry entitled \"Qualification Process for Drug Development Tools\" that described the process that would be used to qualify drug development tools (DDTs) and to make new DDT qualification recommendations available on FDA's Web site. The qualification recommendations in this draft guidance were developed using the process described in that guidance.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2015/07/07/2015-16563.html","cfr_references":[],"citation":"80 FR 38694","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 September 8, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-2244"],"dockets":[],"document_number":"2015-16563","effective_on":null,"end_page":38695,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/07/07/2015-16563.xml","html_url":"https://www.federalregister.gov/documents/2015/07/07/2015-16563/qualification-of-biomarker-plasma-fibrinogen-in-studies-examining-exacerbations-andor-all-cause","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-16563?publication_date=2015-07-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-07-07/2015-16563/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":290,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-07-07/pdf/2015-16563.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-16563.pdf?1436186776","publication_date":"2015-07-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/07/07/2015-16563.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-2015-D-2244","supporting_documents_count":0,"docket_id":"FDA-2015-D-2244","regulation_id_number":null,"title":"Qualification of Biomarker--Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease","checked_regulationsdotgov_at":"2015-09-09T05:02:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38694,"subtype":null,"title":"Qualification of Biomarker-Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease; Draft Guidance for Industry; Availability","toc_doc":"Qualification of Biomarker-Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}