Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability
Document ID: FDA-2009-D-0539-0001
Comments
Total: 13
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Novo Nordisk Inc. - Comment
Posted : 01/27/2010 ID :FDA-2009-D-0539-0004 Agency : FDA -
Feb 02,2010 11:59 PM ET
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MedImmune - Comment
Posted : 02/01/2010 ID :FDA-2009-D-0539-0005 Agency : FDA -
Feb 02,2010 11:59 PM ET
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European Bioanalysis Forum - Interest Group Macromolecules - Comment
Posted : 02/01/2010 ID :FDA-2009-D-0539-0006 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Covance Laboratories Inc. - Comment
Posted : 02/02/2010 ID :FDA-2009-D-0539-0010 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Amgen, Inc. - Comment
Posted : 02/02/2010 ID :FDA-2009-D-0539-0011 Agency : FDA -
Feb 02,2010 11:59 PM ET
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European Immunogenicity Platform (EIP) - Comment
Posted : 02/02/2010 ID :FDA-2009-D-0539-0013 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Facet Biotech - Comment
Posted : 02/02/2010 ID :FDA-2009-D-0539-0015 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Merck & Company - Comment
Posted : 02/03/2010 ID :FDA-2009-D-0539-0017 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Biogen Idec - Comment
Posted : 02/03/2010 ID :FDA-2009-D-0539-0018 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Biotechnology Industry Organization (BIO) - Comment
Posted : 02/03/2010 ID :FDA-2009-D-0539-0019 Agency : FDA -
Feb 02,2010 11:59 PM ET
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bioLOGICA Consulting - Comment
Posted : 02/05/2010 ID :FDA-2009-D-0539-0020 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Covance - Comment
Posted : 02/05/2010 ID :FDA-2009-D-0539-0021 Agency : FDA -
Feb 02,2010 11:59 PM ET
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Human Genome Sciences, Inc. (HGS) - Comment
Posted : 02/05/2010 ID :FDA-2009-D-0539-0022 Agency : FDA -
Feb 02,2010 11:59 PM ET