Federal Register notice: FDA seeks comments on an information collection extension request for Medical Devices; Device Tracking 21 CFR Part 821.
FDA releases an FDA-483 with 14 observations from an inspection at Pfizers Meridian Medical Technologies facility that manufactures combination drug/d...
FDA clears an Instrumentation Laboratory 510(k) for the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls.
Under fire from injured patients, CDRH gains commissioner Scott Gottliebs praise for a pioneering patient engagement effort in a new advisory committe...
Federal Register notice: FDA classifies nucleic acid-based devices for the amplification, detection, and identification of microbial pathogens directl...
FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for treating certain patients with locally advanced, unresect...
Federal Register notice: FDA classifies automated image assessment systems for microbial colonies on solid culture media into Class 2 (special control...
FDA warns Kelynian Global about Quality System and other violations in its manufacturing of custom cranial implants.