Zdrowie i gospodarka · 23/04/2021

FDA to Host Public Workshop on Model-Informed Drug Development Approaches for Immunogenicity Assessments

The FDA is hosting a public workshop to discuss best practices and future directions for predicting immunogenicity of biological products, as part of its performance goals under the Prescription Drug User Fee Amendments (PDUFA VI) and the FDA Reauthorization Act of 2017 (FDARA)