FDA classifies as Class 1 a Medtronic recall of its Dual Chamber Implantable Pulse Generators due to the possibility of a software error that can resu...
Federal Register notice: FDA determines that Schering-Plough Healthcare Products Lotrimin (clotrimazole) topical solution, 1%, was not withdrawn from ...
FDA names Kaveeta Vasisht as Office of Womens Health deputy director.
FDA warns Circulatory Technology about Quality System violations in its work as a specification developer for two medical devices.
FDA accepts a Sarepta Therapeutics NDA) seeking accelerated approval for golodirsen (SRP-4053), indicated for treating those individuals with Duchenne...
Federal Register notice: FDA makes available a draft guidance entitled CDERs Program for the Recognition of Voluntary Consensus Standards Related to P...
Federal Register notice: FDA announces the withdrawal of a Takeda Pharmaceuticals NDA for Omontys (peginesatide) injection, indicated for treating ane...
FDA warns Phoenix-based Vitalab about producing purportedly sterile drugs in insanitary conditions.