EBF-IGM collected, evaluated and merged the comments from her member companies on the "FDA Draft Guidance: Assay Development for Immunogenicity Testing of Therapeutic Proteins" into one consolidated document. This 24 page document was uploaded to the regulations.gov site (docket FDA-2009-D-0539) on Saturday 30 January and can be assessed via this link.EBF welcomed the chance the be able to provide input on this draft guideline and is proud of her EBF-IGM members for pulling this together in such a short time during the holiday period.
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