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
2016_register
executive
2016-05-14
article
Considerations for Use of Histopathology and Its Associated Methodologies To Support Biomarker Qualification; Guidance for Industry; Availability
Notices
D09002ee1bdc1b57b
D09002ee1bdc1b60f
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) is announcing the availability of a guidance for industry entitled ``Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification.'' This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical biomarker qualification studies in which histopathology is used as a reference or truth standard. This guidance discusses the processes that we recommend be considered when generating histopathology data to be included in biomarker studies and outlines the scientific standards recommended for histopathology used in nonclinical biomarker characterization and qualification. The recommendations in this guidance are intended for confirmatory studies in nonclinical biomarker qualification that justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histopathologic changes is essential. The principles outlined in this guidance are also applicable to exploratory nonclinical biomarker studies. This guidance finalizes the draft guidance ``Use of Histology in Biomarker Qualification Studies,'' issued in December 2011.
81 FR 30310
https://www.govinfo.gov/app/details/FR-2016-05-16/2016-11438
2016-11438
fr16my16-84
4164-01-P
Docket No. FDA-2011-D-0872
https://www.govinfo.gov/app/details/FR-2016-05-16/2016-11438
https://www.govinfo.gov/content/pkg/FR-2016-05-16/html/2016-11438.htm
https://www.govinfo.gov/content/pkg/FR-2016-05-16/pdf/2016-11438.pdf
2 p.
30310
30311
81 FR 30310
Considerations for Use of Histopathology and Its Associated Methodologies To Support Biomarker Qualification; Guidance for Industry; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-11438
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-D-0872
4164-01-P
2016-11438
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification.'' This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical biomarker qualification studies in which histopathology is used as a reference or truth standard. This guidance discusses the processes that we recommend be considered when generating histopathology data to be included in biomarker studies and outlines the scientific standards recommended for histopathology used in nonclinical biomarker characterization and qualification. The recommendations in this guidance are intended for confirmatory studies in nonclinical biomarker qualification that justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histopathologic changes is essential. The principles outlined in this guidance are also applicable to exploratory nonclinical biomarker studies. This guidance finalizes the draft guidance ``Use of Histology in Biomarker Qualification Studies,'' issued in December 2011.
Submit either electronic or written comments on Agency guidances at any time.
Elizabeth Hausner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4145, Silver Spring, MD 20993-0002, 301- 796-1084.
Guidance:
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 94
Office of the Federal Register, National Archives and Records Administration
2016-05-16
continuing
daily
deposited
born digital
335 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-05-16
P0b002ee18f74885b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr16my16
https://www.govinfo.gov/app/details/FR-2016-05-16
https://www.govinfo.gov/content/pkg/FR-2016-05-16/pdf/FR-2016-05-16.pdf
https://www.govinfo.gov/content/pkg/FR-2016-05-16/xml/FR-2016-05-16.xml
fdlp
30157
30481
DGPO
2016-05-14
2023-04-29
FR-2016-05-16
machine generated
eng
FR
FR-2016-05-16
81
94