Topic: FDA news


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?”
FDA sign

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.