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International Conference on Harmonisation: Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals

Document ID: FDA-2013-N-0222-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2013-06145
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Details Information

Document Subtype:	General Notice
Received Date:	March 18 2013, at 12:00 AM Eastern Daylight Time
Start-End Page:	16681 - 16684
Page Count:	4
Comment Start Date:	March 18 2013, at 12:00 AM Eastern Standard Time
Comment Due Date:	May 17 2013, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 Rodent Leydig Cell Tumorigenesis A Review of the Physiology Pathology Mechanisms and Relevance to Humans

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Reference 2 The Significance of Hepatic Microsomal Enzyme Induction and Altered Thyroid Function in Rats Implications for Thyroid Gland Neoplasia

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Comments

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Total: 11

American Chemistry Council (ACC) - Comment
Posted: 05/21/2013 ID: FDA-2013-N-0222-0006

Comment Period Closed
May 17,2013 11:59 PM ET

Bristol-Myers Squibb - Comment
Posted: 05/21/2013 ID: FDA-2013-N-0222-0007

Comment Period Closed
May 17,2013 11:59 PM ET

Society of Toxicologic Pathology - Comment
Posted: 05/21/2013 ID: FDA-2013-N-0222-0002

Comment Period Closed
May 17,2013 11:59 PM ET

Novartis Pharmaceuticals Corp. - Comment
Posted: 05/21/2013 ID: FDA-2013-N-0222-0004

Comment Period Closed
May 17,2013 11:59 PM ET

BioReliance - Comment
Posted: 05/21/2013 ID: FDA-2013-N-0222-0010

Comment Period Closed
May 17,2013 11:59 PM ET

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