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Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity

Jennifer K Lee1, Ha-Na Lee2, Sudhir Agrawal3

  • 1Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

The AAPS Journal
|February 12, 2026
PubMed

Keywords:
genericsimmunogenicity risk assessmentimpuritiesoligonucleotide productspeptide products

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