{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.\" This draft guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The draft guidance includes factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate. Oncology companion diagnostics with broader evidence-based indications will optimally facilitate clinical use.","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/2018/12/07/2018-26554.html","cfr_references":[],"citation":"83 FR 63166","comment_url":null,"comments_close_on":"2019-02-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 5, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2018-D-3380"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":16,"comment_start_date":"2018-12-07","updated_at":"2023-02-28T21:08:51.845-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-3380-0001","allow_late_comments":null,"id":"FDA-2018-D-3380-0001","comment_end_date":"2019-02-06","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-3380","title":"Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry; Availability "}],"document_number":"2018-26554","effective_on":null,"end_page":63167,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/07/2018-26554.xml","html_url":"https://www.federalregister.gov/documents/2018/12/07/2018-26554/developing-and-labeling-in-vitro-companion-diagnostic-devices-for-a-specific-group-or-class-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-26554?publication_date=2018-12-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-07/2018-26554/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":934,"last_updated":"2026-08-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/2018-26554.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-26554.pdf?1544103921","publication_date":"2018-12-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/07/2018-26554.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":16,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-3380","supporting_documents_count":0,"docket_id":"FDA-2018-D-3380","document_id":"FDA-2018-D-3380-0001","regulation_id_number":null,"title":"Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-03-01T02:08:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":63166,"subtype":null,"title":"Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry; Availability","toc_doc":"Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}