Zdrowie i gospodarka · 25/04/2016

FDA Releases Revised Draft Guidance for Industry on Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

The FDA has made available a revised draft guidance for industry on assay development and validation for immunogenicity testing of therapeutic protein products, providing recommendations for industry to develop and validate immune assays for assessing immunogenicity during clinical trials.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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