Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input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.
Article Biochemical Assays Clinical Development 
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Analysis Life Sciences Thank You Amid broader shift on LDT policy, FDA unveils pilot program for cancer drug-linked tests and diagnostics
Agency IQ
JUNE 26, 2023
Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g., serum creatinine or transaminases) that are used to monitor organ function, but are not essential for the safe and effective use of a therapeutic product.”
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