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2012-12-15
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Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability
Notices
D09002ee1bdcad123
D09002ee1bdcad197
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials.
77 FR 74670
https://www.govinfo.gov/app/details/FR-2012-12-17/2012-30274
2012-30274
fr17de12-52
4160-01-P
Docket No. FDA-2012-D-1145
https://www.govinfo.gov/app/details/FR-2012-12-17/2012-30274
https://www.govinfo.gov/content/pkg/FR-2012-12-17/html/2012-30274.htm
https://www.govinfo.gov/content/pkg/FR-2012-12-17/pdf/2012-30274.pdf
2 p.
74670
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77 FR 74670
Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability; Federal Register Vol. 77, Issue
NOTICE
2012-30274
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2012-D-1145
4160-01-P
2012-30274
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 15, 2013.
Robert Temple, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4212, Silver Spring, MD 20993-0003, 301- 796-2270; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Robert L. Becker, Center for Device and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5674, Silver Spring, MD 20993-0003, 301-796-5450.
Draft Guidances for Industry; Availability, etc.:
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 77, no. 242
Office of the Federal Register, National Archives and Records Administration
2012-12-17
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230 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2012-12-17
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https://www.govinfo.gov/app/details/FR-2012-12-17
https://www.govinfo.gov/content/pkg/FR-2012-12-17/pdf/FR-2012-12-17.pdf
https://www.govinfo.gov/content/pkg/FR-2012-12-17/xml/FR-2012-12-17.xml
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