Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input
Agency IQ
APRIL 12, 2024
For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”
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