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# Immunogenicity Drug Labeling Guidance
- URL: https://www.fdaweb.com/immunogenicity-drug-labeling-guidance/
- Published: 2022-02-04T12:00:00.000Z
- Updated: 2026-09-14T17:31:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151083

*Federal Register* notice: FDA is making available a draft guidance entitled “Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format.” The document provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-04/pdf/2022-02348.pdf?ref=fdaweb.com).