federal_register: E9-28960

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-28960 Draft Guidance for Industry on Assay Development for Immunogenicity Testing of Therapeutic Proteins; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Assay Development for Immunogenicity Testing of Therapeutic Proteins." The draft guidance provides recommendations to facilitate industry's development of immune assays for assessment of the immunogenicity of therapeutic proteins during clinical trials. 2009-12-04 2009 12 https://www.federalregister.gov/documents/2009/12/04/E9-28960/draft-guidance-for-industry-on-assay-development-for-immunogenicity-testing-of-therapeutic-proteins https://www.govinfo.gov/content/pkg/FR-2009-12-04/pdf/E9-28960.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Assay Development for Immunogenicity Testing of Therapeutic Proteins." The draft guidance provides recommendations to facilitate industry's...

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