Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input
Agency IQ
APRIL 12, 2024
BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” morphological cell changes or alterations in protein production or expression).
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