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FDA releases the form FDA-483 with five observations from an inspection at the Torrent Pharmaceuticals facility in Indrad, Gujarat...[ Price : $8.95]
FDA grants a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System for detecting hepatitis...[ Price : $8.95]
CDRH says it is partnering with the Bill and Melinda Gates Foundation and the National Institute for Standards and Technology on a...[ Price : $8.95]
Federal Register notice: FDA submits to OMB a proposed information collection entitled Voluntary Total Product Life Cycle (TPLC) A...[ Price : $8.95]
Federal Register notice: FDA requests comments on its Information Technology Strategy and Customer Experience Strategy.[ Price : $8.95]
FDA clears a Tempus AI 510(k) for its Tempus ECG-AF device that uses artificial intelligence to help identify patients at increase...[ Price : $8.95]
FDA clears a Fujifilm Healthcare Americas 510(k) for its new compact, 128-slice computed tomography (CT) system, the FCT iStream.[ Price : $8.95]
Public Citizen recommends three steps FDA should take to improve the public perception and understanding of the work of agency adv...