FDA Issues Draft Guidance on Immunogenicity Information in Prescription Drug Labeling Today, the U.S. Food and Drug Administration issued the draft guidance for industry "Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format." The purpose of this guidance is to assist applicants with incorporating immunogenicity information into the labeling of human prescription biological products—specifically therapeutic protein products (e.g., monoclonal antibodies, enzymes)—and of select drug products that have immunogenicity assessments (e.g., peptides, oligonucleotides, low molecular weight heparins). Immunogenicity is the propensity of a therapeutic protein product or other applicable drug product to generate an immune response to itself, a related structure, or product complex, and/or to induce immunologically related adverse clinical events. Some, but not all, anti-drug antibodies have been associated with safety concerns or loss of effectiveness. By providing clinically relevant immunogenicity information in the labeling in a consistent manner, health care practitioners can easily access, understand, and use this information to inform prescribing decisions and patient management, and to support safe and effective use of applicable products. This guidance recommends the use of a new dedicated Immunogenicity subsection in the Clinical Pharmacology section that will allow for a consistent location for summarizing immunogenicity data in one location in the labeling. This guidance describes: - Information and statements to include in the Immunogenicity subsection
- Recommended immunogenicity information to include in other subsections and sections of the labeling, when appropriate
- Recommendations for updating immunogenicity information in the labeling
FDA is accepting comments and suggestions on this draft guidance. For more information, please refer to docket number FDA-2021-D-1041. |
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