Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments

Affiliations

• ¹ Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
• ² Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
• ³ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
• ⁴ Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.