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...
New research supported by CDRHs Division of Biostatistics outlines an approach that could lead to more patient-reported outcome measures to be include...
Federal Register notice: FDA announces a12/4-5 Circulatory System Devices Panel of the Medical Devices Advisory Committee.
Abbott Laboratories and its spin-off AbbVie agree to pay $25 million to resolve allegations that they used kickbacks and off-label marketing and promo...