Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling–Content and Format

This guidance provides recommendations to help ensure that clinically relevant immunogenicity information is included and distributed appropriately across sections and subsections of product labeling, in accordance with regulatory requirements for the content and format of human prescription drug and biological product labeling. The goal of appropriate inclusion and distribution of clinically relevant immunogenicity information in the labeling is to enable health care practitioners to easily access, understand, and use this information to inform prescribing decisions and patient management, and to help enable safe and effective use of applicable products.

When finalized, this guidance will supersede the immunogenicity labeling-specific recommendations in the guidance for industry entitled “Labeling for Biosimilar Products” and “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.”