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Home » EMA Revises Draft Guidance for Proposed Immunoglobulin Biologics
EMA Revises Draft Guidance for Proposed Immunoglobulin Biologics
The EMA published a third revision to its guideline for human normal immunoglobulin for intravenous use, covering biological data, pharmacokinetics, clinical trials and patient follow-up, as well as changes in the manufacturing process of previously authorized products.