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www.fdanews.com/articles/177324-industry-calls-on-fda-to-clarify-protein-based-treatments-guidance

Industry Calls on FDA to Clarify Protein-Based Treatments Guidance

June 30, 2016

Industry is asking the FDA to clarify key elements of its updated draft guidance on assessing the effects of protein-based treatments on the immune system.

Chief among their concerns is the document’s recommendation that the initial screening assay be sensitive to low levels of different forms of anti-drug antibodies, which can provoke an immune response in patients.

The FDA previously released the updated draft guidance in April, providing advice on how to validate results. The document made few substantive changes from the 2009 edition, mostly reorganizing its recommendations into a more logical fashion.

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