On 3 December FDA released their draft guideline on immunogenicity testing on their website:
Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins
The consultation period is 60 days.
News and announcements of the European Bioanalysis Forum (EBF)
On 3 December FDA released their draft guideline on immunogenicity testing on their website:
Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins
The consultation period is 60 days.
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