This article was originally published in The Gray Sheet
FDA issues a final 1guidance document June 7 on preparing 510(k)s and labeling for assayed and unassayed quality control materials that are intended to monitor reliability of a diagnostic system and help minimize reporting of incorrect results. The document follows a 1999 draft version (2"The Gray Sheet" Feb. 8, 1999, p. 32)...
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Comments on FDA's draft guidance document on the materials published in the Feb. 3 Federal Register are due within 90 days.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"
Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020.
Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.