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Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemicalassays (e.g., Featuring previous research by Amanda Conti. The FDA expects that CDx will be approved with a drug, but that’s not always feasible.
Assays are tests designed to assess various properties (like potency) of chemical or biological samples. The Pharmaceutical Research and Manufacturers of America (PhRMA) also voiced this concern, asking the FDA to provide “additional detail regarding phase appropriate implementation.”
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