United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2018_register executive 2018-12-07 article Notices D09002ee1c7ddde1e D09002ee1c7dde02a United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products." This draft guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to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 The draft guidance includes factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate.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. 83 FR 63166 https://www.govinfo.gov/app/details/FR-2018-12-07/2018-26554 2018-26554 fr07de18-41 4164-01-P Docket No. FDA-2018-D-3380 https://www.govinfo.gov/app/details/FR-2018-12-07/2018-26554 https://www.govinfo.gov/content/pkg/FR-2018-12-07/html/2018-26554.htm https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/2018-26554.pdf 2 p. 63166 63167 83 FR 63166 Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry; Availability; Federal Register Vol. 83, Issue NOTICE 2018-26554 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2019-02-05 Docket No. FDA-2018-D-3380 4164-01-P 2018-26554 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products." This draft guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to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.

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. Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911; Reena Philip, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5680, Silver Spring, MD 20993-0002, 301-796-6179; or Julie Schneider, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2208, Silver Spring, MD 20993-0002, 240-402-4658. Guidance: Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products , https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 235 Office of the Federal Register, National Archives and Records Administration 2018-12-07 continuing daily deposited born digital 349 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-12-07 P0b002ee19e10a9db 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07de18 https://www.govinfo.gov/app/details/FR-2018-12-07 https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/FR-2018-12-07.pdf https://www.govinfo.gov/content/pkg/FR-2018-12-07/xml/FR-2018-12-07.xml fdlp 63041 63381 DGPO 2018-12-07 2024-06-01 FR-2018-12-07 machine generated eng FR FR-2018-12-07 83 235