Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input
Agency IQ
APRIL 12, 2024
Assays are tests designed to assess various properties (like potency) of chemical or biological samples. In addition to assessing binding capabilities, assays can also be used to characterize the activity elicited by a product, whether bound or unbound to the target of interest. Code in order to have their products approved by the FDA.
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