Topic: FDA news

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Process Characterization: Ready For the FDA?

Eight years after the FDA issued its guidance of process validation, some still ask the question “Is process characterization optional anymore?”
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FDA deems bioMérieux assay tech recall Class I

Molecular diagnostics player bioMérieux issued a recall for its NucliSENS easyMAG Magnetic Silica, which is used in several molecular assays to extract DNA and RNA from biological samples. The FDA has deemed the recall Class I.