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