FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

FDA Issues Guidance on Immunogenicity Tests for Therapeutic Proteins

Jan. 30, 2019

The FDA released guidance for sponsors of therapeutic proteins on developing tests to assess immunogenicity during clinical trials.

The recommendations apply to assays that detect one or more anti-drug antibodies (ADAs) and may also apply, on a case-by-case basis, to certain peptides, oligonucleotides and combination products, the agency said.

Sponsors should use a risk-based approach to evaluate and manage immune responses and immunologically-related adverse events for therapeutic protein products, the agency said.

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