European Bioanalysis Forum - Interest Group Macromolecules (EBF-IGM):
EBF-IGM thanks the FDA for providing a long-awaited document in an area where no or little regulatory advice is available. EBF-IGM welcomes the opportunity to provide FDA with comments on this draft guideline.
The consolidated opinion of 13 EBF-IGM member companies* is summarized in the document attached.
Attachments:
European Bioanalysis Forum - Interest Group Macromolecules - Comment
Title: European Bioanalysis Forum - Interest Group Macromolecules - Comment
European Bioanalysis Forum - Interest Group Macromolecules - Comment
This is comment on Notice
Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability
View Comment
Attachments:
European Bioanalysis Forum - Interest Group Macromolecules - Comment
Title:
European Bioanalysis Forum - Interest Group Macromolecules - Comment
Related Comments
View AllPublic Submission Posted: 01/27/2010 ID: FDA-2009-D-0539-0004
Feb 02,2010 11:59 PM ET
Public Submission Posted: 02/01/2010 ID: FDA-2009-D-0539-0005
Feb 02,2010 11:59 PM ET
Public Submission Posted: 02/02/2010 ID: FDA-2009-D-0539-0010
Feb 02,2010 11:59 PM ET
Public Submission Posted: 02/02/2010 ID: FDA-2009-D-0539-0011
Feb 02,2010 11:59 PM ET
Public Submission Posted: 02/02/2010 ID: FDA-2009-D-0539-0015
Feb 02,2010 11:59 PM ET