federal_register: 2019-00666

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2019-00666 Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Immunogenicity Testing of Therapeutic Protein Products--Developing and Validating Assays for Anti-Drug Antibody Detection." This guidance provides recommendations to facilitate industry's development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. The guidance applies to assays for the detection of anti-drug antibodies (ADAs) and may also apply to some peptides, oligonucleotides, and combination products on a case-by-case basis. The guidance includes recommendations regarding the development and validation of screening assays, confirmatory assays, titration assays, and neutralization assays. This guidance finalizes the revised draft guidance for industry entitled "Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products" issued in April 2016 and includes a revised title. 2019-02-01 2019 2 https://www.federalregister.gov/documents/2019/02/01/2019-00666/immunogenicity-testing-of-therapeutic-protein-products-developing-and-validating-assays-for https://www.govinfo.gov/content/pkg/FR-2019-02-01/pdf/2019-00666.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 final guidance for industry entitled "Immunogenicity Testing of Therapeutic Protein Products--Developing and Validating Assays for Anti-Drug Antibody Detection." This...  

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