| On February 4th, 2022, the FDA announced the availability of a draft guidance for industry entitled Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format. The purpose of this guidance is to assist applicants with incorporating immunogenicity information into the labeling of human prescription biological products—specifically therapeutic protein products (e.g., monoclonal antibodies, enzymes)—and of select drug products that have immunogenicity assessments (e.g., peptides, oligonucleotides, low molecular weight heparins). Immunogenicity is defined as the propensity of a therapeutic protein product or other applicable drug product to generate an immune response to itself, a related structure, or product complex, and/or to induce immunologically related adverse clinical events. Some, but not all, anti-drug antibodies have been associated with safety concerns or loss of effectiveness. By providing clinically relevant immunogenicity information in the labeling in a consistent manner, health care practitioners can easily access, understand, and use this information to inform prescribing decisions and patient management, and to support the safe and effective use of applicable products. This guidance recommends the use of a new dedicated Immunogenicity subsection in the CLINICAL PHARMACOLOGY section that will allow for a consistent location for summarizing immunogenicity data in one location in the labeling. This guidance describes: - Information and statements to include in the Immunogenicity subsection
- Recommended immunogenicity information to include in other subsections and sections of the labeling, when appropriate
- Recommendations for updating immunogenicity information in the labeling
The "Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format" guidance is available at https://go.usa.gov/xtdBa. Please refer to the draft guidance for more details. FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket (Docket No. FDA-2021-D-1041) available at https://www.regulations.gov up to 60 days following publication in the FEDERAL REGISTER. This draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count. |
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