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2016-09-16
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Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Guidance for Industry; Availability
Notices
D09002ee1bdc12347
D09002ee1bdc123df
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Qualification of Biomarker--Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a ``progressive decline'' in renal function, defined as a confirmed 30 percent decline in the patient's estimated glomerular filtration rate (eGFR), for inclusion in interventional clinical trials. This 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.
81 FR 63764
https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22347
2016-22347
fr16se16-67
4164-01-P
Docket No. FDA-2015-D-2843
https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22347
https://www.govinfo.gov/content/pkg/FR-2016-09-16/html/2016-22347.htm
https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/2016-22347.pdf
3 p.
63764
63766
81 FR 63764
Qualification of Biomarker-Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease; Guidance for Industry; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-22347
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-2843
4164-01-P
2016-22347
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Qualification of Biomarker--Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease.'' This guidance provides a qualified context of use (COU) for total kidney volume (TKV), measured at baseline, to be used as a prognostic enrichment biomarker to select patients with autosomal dominant polycystic kidney disease (ADPKD) at high risk for a ``progressive decline'' in renal function, defined as a confirmed 30 percent decline in the patient's estimated glomerular filtration rate (eGFR), for inclusion in interventional clinical trials. This 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.
Submit either electronic or written comments on Agency guidances at any time.
Marianne Noone, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4528, Silver Spring, MD 20993-0002, 301- 796-2600.
Guidance:
Qualification of BiomarkerTotal Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease
,
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm
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. 180
Office of the Federal Register, National Archives and Records Administration
2016-09-16
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Table of Contents:
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KF70.A2
https://www.govinfo.gov/app/details/FR-2016-09-16
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https://www.govinfo.gov/app/details/FR-2016-09-16
https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/FR-2016-09-16.pdf
https://www.govinfo.gov/content/pkg/FR-2016-09-16/xml/FR-2016-09-16.xml
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