Immunogenicity Information in Labeling
April 5, 2022
- April 5, 2022
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ABOUT THIS WEBINAR
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- Discuss the draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022).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
- Draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022).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.
- Prescription Drug Labeling Resources
- Immunogenicity development guidances:
- Immunogenicity Assessment for Therapeutic Protein Products (August 2014)
- Immunogenicity Testing of Therapeutic Proteins Developing and Validating Assays for Anti-drug Antibody Detection (January 2019)
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015)
- Considerations in Demonstrating Interchangeability to a Reference Product (May 2019)
- Immunogenicity-Related Considerations for Low Molecular Weight Heparin (February 2016)
- ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (May 2021)