Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability

Document ID: FDA-2009-D-0539-0001

Comments

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

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

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

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

Feb 02,2010 11:59 PM ET
European Immunogenicity Platform (EIP) - Comment
Posted : 02/02/2010     ID :FDA-2009-D-0539-0013     Agency : FDA

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

Feb 02,2010 11:59 PM ET
Merck & Company - Comment
Posted : 02/03/2010     ID :FDA-2009-D-0539-0017     Agency : FDA

Feb 02,2010 11:59 PM ET
Biogen Idec - Comment
Posted : 02/03/2010     ID :FDA-2009-D-0539-0018     Agency : FDA

Feb 02,2010 11:59 PM ET
Biotechnology Industry Organization (BIO) - Comment
Posted : 02/03/2010     ID :FDA-2009-D-0539-0019     Agency : FDA

Feb 02,2010 11:59 PM ET
bioLOGICA Consulting - Comment
Posted : 02/05/2010     ID :FDA-2009-D-0539-0020     Agency : FDA

Feb 02,2010 11:59 PM ET
Covance - Comment
Posted : 02/05/2010     ID :FDA-2009-D-0539-0021     Agency : FDA

Feb 02,2010 11:59 PM ET
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