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  4. Immunogenicity Information in Labeling - 04/05/2022
  1. News & Events for Human Drugs

Webcast | Virtual

Event Title
Immunogenicity Information in Labeling
April 5, 2022

April 5, 2022


Presentation Slides

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During this webinar, FDA will:

  • Highlight why immunogenicity is important to consider for drug development
  • Discuss the draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022). When final, this guidance will represent FDA’s current thinking on this topic.
  • Discuss creation of the new dedicated subsection 12.6 for immunogenicity information (Immunogenicity subsection) in the CLINICAL PHARMACOLOGY section of labeling
  • Provide an overview on how to develop the Immunogenicity subsection
  • Describe when and how to incorporate immunogenicity information in other sections of labeling
  • Provide recommendations on when to update immunogenicity information in labeling


Pharmaceutical industry staff who include immunogenicity information in labeling for their biological products [specifically human therapeutic protein products licensed under section 351(a) of the Public Health Service Act] and certain select drug products (regulated under section 505 of the Federal Food, Drug, and Cosmetic Act) with immunogenicity assessments (e.g., heparins, oligonucleotides, and peptides).


Daphne Guinn, Ph.D.
Regulatory Health Project Manager
Office of Clinical Pharmacology (OCP)
Office of Translational Science (OTS) | CDER | FDA

Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA


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