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Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for our partners in the pharmaceutical and healthcare industry.

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    FDA Issues Draft Guidance on Immunogenicity Assessment of Therapeutic Proteins
    February 2012
    The FDA issued a draft guidance which is intended to assist manufacturers and clinical investigators involved in the development of therapeutic proteins for human use. FDA outlines and recommends adoption of a risk-based approach to evaluating and mitigating immune responses to therapeutic proteins that may adversely affect their safety and efficacy For more information, click here