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Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability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

    View All
Total: 13
Novo Nordisk Inc. - Comment
Posted: 01/27/2010     ID: FDA-2009-D-0539-0004

Feb 02,2010 11:59 PM ET
MedImmune - Comment
Posted: 02/01/2010     ID: FDA-2009-D-0539-0005

Feb 02,2010 11:59 PM ET
Covance Laboratories Inc. - Comment
Posted: 02/02/2010     ID: FDA-2009-D-0539-0010

Feb 02,2010 11:59 PM ET
Amgen, Inc. - Comment
Posted: 02/02/2010     ID: FDA-2009-D-0539-0011

Feb 02,2010 11:59 PM ET
Facet Biotech - Comment
Posted: 02/02/2010     ID: FDA-2009-D-0539-0015

Feb 02,2010 11:59 PM ET

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