Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input
Agency IQ
APRIL 12, 2024
Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. for gene therapies that use viral or nonviral vectors).
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