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FDA releases an FDA-483 with 14 observations from an inspection at Pfizers Meridian Medical Technologies facility that manufacture...[ Price : $8.95]
FDA clears an Instrumentation Laboratory 510(k) for the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls.[ Price : $8.95]
Under fire from injured patients, CDRH gains commissioner Scott Gottliebs praise for a pioneering patient engagement effort in a n...[ Price : $8.95]
Federal Register notice: FDA classifies nucleic acid-based devices for the amplification, detection, and identification of microbi...[ Price : $8.95]
FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for treating certain patients with locall...[ Price : $8.95]
Federal Register notice: FDA classifies automated image assessment systems for microbial colonies on solid culture media into Clas...[ Price : $8.95]
FDA warns Kelynian Global about Quality System and other violations in its manufacturing of custom cranial implants.[ Price : $8.95]
FDA warns the third Diasol facility this month about Quality System and other violations in its manufacturing of liquid and powder...