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Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability

Document ID: FDA-2009-D-0539-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: E9-28960
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Details Information

Document Subtype:	NAD-Notice of Availability of Data
Received Date:	December 04 2009, at 10:30 AM Eastern Standard Time
Start-End Page:	63758 - 63758
Page Count:	1
Comment Start Date:	December 4 2009, at 12:00 AM Eastern Standard Time
Comment Due Date:	February 2 2010, at 11:59 PM Eastern Standard Time

Comments

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Total: 13

Novo Nordisk Inc. - Comment
Posted: 01/27/2010 ID: FDA-2009-D-0539-0004

Comment Period Closed
Feb 02,2010 11:59 PM ET

MedImmune - Comment
Posted: 02/01/2010 ID: FDA-2009-D-0539-0005

Comment Period Closed
Feb 02,2010 11:59 PM ET

Covance - Comment
Posted: 02/05/2010 ID: FDA-2009-D-0539-0021

Comment Period Closed
Feb 02,2010 11:59 PM ET

European Immunogenicity Platform (EIP) - Comment
Posted: 02/02/2010 ID: FDA-2009-D-0539-0013

Comment Period Closed
Feb 02,2010 11:59 PM ET

European Bioanalysis Forum - Interest Group Macromolecules - Comment
Posted: 02/01/2010 ID: FDA-2009-D-0539-0006

Comment Period Closed
Feb 02,2010 11:59 PM ET

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