Draft guidance on potency assays for CGT products garners extensive stakeholder input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. Now, the deadline for feedback to that draft guidance has passed, and AgencyIQ has an analysis of the comments here.

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.” The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data.

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