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Federal Register notice: FDAs chief scientist denies a request for a hearing on a CDER proposal to refuse approval of a Pharmaceut...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that include Boule Medical, Cardiomed Supplies, Gaeltec Devices and Leventon.[ Price : $8.95]
FDA warns Spains Leventon S.A.U. about Quality System violations in its manufacturing of Dosi Flow infusion pumps and administrati...[ Price : $8.95]
Three medical school professors ask FDA to add warning language about sexual side effects to labeling for all drug products contai...[ Price : $8.95]
Federal Register notice: FDA classifies the active implantable bone conduction hearing system into Class 2 (special controls).[ Price : $8.95]
Federal Register notice: FDA classifies high-flow humidified oxygen delivery devices into Class 2 (special controls).[ Price : $8.95]
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Novo Nordisks Rebin...[ Price : $8.95]
FDA clears an Align Technology 510(k) for the Invisalign treatment with mandibular advancement, a clear aligner solution for Class...