FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

FDA Issues Guidance on Immunogenicity Tests for Therapeutic Proteins

Jan. 30, 2019
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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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