# Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/immunogenicity-information-in-human-prescription-therapeutic-protein-and-select-drug-product-labeling-content-and-format-draft-guidance-for-industry/7ecfa0a7-217f-451f-a5d5-0ffe4d7afd5d

> FDA guidance document: Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry. Issue date: February 03, 2022. Get complete insights and analysis.

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## Details

- Title: Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2022-02-03
- Comment Close Date: 2022-04-05
- Last Changed: 2025-02-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-1041">FDA-2021-D-1041</a>

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