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 2012_register executive 2012-12-22 article Notices D09002ee1c7fc09f3 D09002ee1c7fc0ac7 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), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). Our objective is for the workshop to provide a venue for an in-depth discussion of potential endpoints for trials intended to support the approval of new drugs or biologics for treatment of AML. Participants in the workshop will examine if any currently used biomarker can be used as a surrogate endpoint, identify the preferred technology platform and performance characteristics for the assay of the biomarker, discuss any issues regarding ongoing deficiencies in methodological standardization for the biomarker, and determine the need for additional FDA-approved in-vitro diagnostics for AML drug development. The primary focus will be on the biomarkers that are or will soon be ready for incorporation into clinical trials, and the technical and regulatory challenges for use of these markers. 77 FR 76050 https://www.govinfo.gov/app/details/FR-2012-12-26/2012-31043 2012-31043 fr26de12-111 4160-01-P Docket No. FDA-2012-N-0001 https://www.govinfo.gov/app/details/FR-2012-12-26/2012-31043 https://www.govinfo.gov/content/pkg/FR-2012-12-26/html/2012-31043.htm https://www.govinfo.gov/content/pkg/FR-2012-12-26/pdf/2012-31043.pdf 2 p. 76050 76051 77 FR 76050 Public Workshop on Minimal Residual Disease; Public Workshop; Federal Register Vol. 77, Issue NOTICE 2012-31043 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-0001 4160-01-P 2012-31043 Notice of public workshop.

The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). Our objective is for the workshop to provide a venue for an in-depth discussion of potential endpoints for trials intended to support the approval of new drugs or biologics for treatment of AML. Participants in the workshop will examine if any currently used biomarker can be used as a surrogate endpoint, identify the preferred technology platform and performance characteristics for the assay of the biomarker, discuss any issues regarding ongoing deficiencies in methodological standardization for the biomarker, and determine the need for additional FDA-approved in-vitro diagnostics for AML drug development. The primary focus will be on the biomarkers that are or will soon be ready for incorporation into clinical trials, and the technical and regulatory challenges for use of these markers.

The public workshop will be held on March 4, 2013, from 8 a.m. to 4 p.m. Christine Lincoln, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993-0002, 301- 796-2340, email: Christine.Lincoln@fda.hhs.gov. Public Workshops: Minimal Residual Disease , Christine.Lincoln@fda.hhs.gov http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/AdvisoryCommittees/default.htm http://www.zoomerang.com/Survey/WEB22GPAXN9NQB Vol. 77, no. 247 Office of the Federal Register, National Archives and Records Administration 2012-12-26 continuing daily deposited born digital 402 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-12-26 P0b002ee1839c2d36 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26de12 https://www.govinfo.gov/app/details/FR-2012-12-26 https://www.govinfo.gov/content/pkg/FR-2012-12-26/pdf/FR-2012-12-26.pdf https://www.govinfo.gov/content/pkg/FR-2012-12-26/xml/FR-2012-12-26.xml fdlp 75823 76213 DGPO 2012-12-22 2024-06-03 FR-2012-12-26 machine generated eng FR FR-2012-12-26 77 247