federal_register: 2016-09449

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2016-09449 Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products; Revised Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products." This guidance provides recommendations to facilitate industry's development and validation of immune assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. The guidance for assay development and validation provided in this document applies to assays for detection of anti-drug antibodies (ADA). This document includes guidance regarding the development and validation of screening assays, confirmatory assays, titering assays, and neutralization assays. This guidance revises the draft guidance for industry entitled "Assay Development for Immunogenicity Testing of Therapeutic Proteins" issued in December 2009. This revised draft guidance includes new information on titering and confirmatory assays. 2016-04-25 2016 4 https://www.federalregister.gov/documents/2016/04/25/2016-09449/assay-development-and-validation-for-immunogenicity-testing-of-therapeutic-protein-products-revised https://www.govinfo.gov/content/pkg/FR-2016-04-25/pdf/2016-09449.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products." This guidance provides...  

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