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2013-03-16
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International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals; Request for Comments
Notices
D09002ee1bdca7af2
D09002ee1bdca7b5e
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 the Agency) is considering a proposed change to the International Conference on Harmonisation (ICH) Sl guidance on rodent carcinogenicity testing. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2- year rodent carcinogenicity studies add value to that assessment. The basis of this proposed change is the retrospective analyses of several datasets that reflect three decades of experience with such studies. The datasets suggest that knowledge of certain pharmacologic and toxicologic data can sometimes provide sufficient information to anticipate the outcome of 2-year rodent studies and their potential value in predicting the risk of human carcinogenicity of a given pharmaceutical. FDA is requesting public comment regarding a proposed change in approach to carcinogenicity assessment, on the prospective evaluation period intended to test this new approach, and on the proposed weight-of-evidence factors for carcinogenicity assessment.
78 FR 16681
https://www.govinfo.gov/app/details/FR-2013-03-18/2013-06145
2013-06145
fr18mr13-49
4160-01-P
Docket No. FDA-2013-N-0222
https://www.govinfo.gov/app/details/FR-2013-03-18/2013-06145
https://www.govinfo.gov/content/pkg/FR-2013-03-18/html/2013-06145.htm
https://www.govinfo.gov/content/pkg/FR-2013-03-18/pdf/2013-06145.pdf
4 p.
16681
16684
78 FR 16681
International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals; Request for Comments; Federal Register Vol. 78, Issue
NOTICE
2013-06145
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2013-05-17
Docket No. FDA-2013-N-0222
4160-01-P
2013-06145
Notice; request for comments.
The Food and Drug Administration (FDA or the Agency) is considering a proposed change to the International Conference on Harmonisation (ICH) Sl guidance on rodent carcinogenicity testing. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2- year rodent carcinogenicity studies add value to that assessment. The basis of this proposed change is the retrospective analyses of several datasets that reflect three decades of experience with such studies. The datasets suggest that knowledge of certain pharmacologic and toxicologic data can sometimes provide sufficient information to anticipate the outcome of 2-year rodent studies and their potential value in predicting the risk of human carcinogenicity of a given pharmaceutical. FDA is requesting public comment regarding a proposed change in approach to carcinogenicity assessment, on the prospective evaluation period intended to test this new approach, and on the proposed weight-of-evidence factors for carcinogenicity assessment.
Submit electronic or written comments on the proposed change by May 17, 2013.
Todd Bourcier, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3102, Silver Spring, MD 20993-0002, 301- 796-1179.
International Conference on Harmonisation:
Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 52
Office of the Federal Register, National Archives and Records Administration
2013-03-18
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185 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2013-03-18
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https://www.govinfo.gov/content/pkg/FR-2013-03-18/xml/FR-2013-03-18.xml
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