Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format Draft Guidance for Industry February 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2021-D-1041
• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format.” This draft guidance provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments. Appropriate inclusion and consistent placement of immunogenicity information in the Prescribing Information helps to make clinically relevant information accessible to the health care practitioner and promotes the safe and effective use of prescription drug and biological products. When finalized, the recommendations in this guidance will supersede the immunogenicity labeling-specific recommendations in the guidances for industry entitled “Labeling for Biosimilar Products” and “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.”

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