Assayed and unassayed quality control material
Comments on FDA's draft guidance document on the materials published in the Feb. 3 Federal Register are due within 90 days. FDA specifically requests input on the document's recommendation that sponsors evaluate control materials for the effects of the materials being tested. "New and unusual non-human matrices (materials such as blood, serum, or urine from animals) are becoming more common" and FDA "believes it is important for the user to know if a matrix bias exists." The agency also seeks comments on its suggestion that each QC material be evaluated for its "ability to detect variables in assay conditions that have an impact on patient sample results"
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