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GUIDANCE DOCUMENT

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Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format Draft Guidance for Industry February 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-1041

Docket Number:
FDA-2021-D-1041
Issued by:
Guidance Issuing Office
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The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format.” This draft guidance provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments.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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