Drugs

Immunogenicity Information Guidance

FDA has published a draft guidance, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format, to assist applicants with incorporating immunogenicity information into the labeling of human prescription biological products, specifically therapeutic protein products and of select drug products that have immunogenicity assessments. The document “provides recommendations to help ensure that clinically relevant immunogenicity information is included in and distributed appropriately across sections and subsections of product labeling,” FDA says.

The guidance says the goal of appropriate inclusion and distribution of clinically relevant immunogenicity information in the labeling is to enable healthcare practitioners to easily access, understand, and use the information to inform prescribing decisions and patient management, and to help enable safe and effective use of applicable products.

When finalized, the guidance will supersede applicable provisions in guidances from 7/2018 and 12/2016.

The guidance contents cover Introduction, Background, General Principles, Immunogenicity Subsection Under the Clinical Pharmacology Section, Adverse Reactions Section, Clinical Studies Section, Warnings and Precautions Section, Other Sections of Labeling, and Procedural Information — Updating Immunogenicity Information in the Labeling.

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