Guidance: Development of Immune Assays Key to Product Development

The FDA recommends that drugmakers submitting NDAs include data supporting the full validation of assays related to immunogenicity testing, which gauges the risk of patients developing a harmful immune response to therapeutic proteins, a draft guidance says. Clinicians rely on the data on drug labeling for immunogenicity rates observed during clinical trials, because patient responses vary so widely, according to the draft guidance published in the Dec. 4 Federal Register.
Drug Industry Daily