FDA Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products
Title:
FDA Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf
Content:
In this document, 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