FDA posts two final guidance documents on regenerative medicine therapies as part of the agencys comprehensive regenerative medicine policy framework....
Federal Register notice: FDA seeks comments on an information collection extension for Exports: Notification and Recordkeeping Requirements 21 CFR 1....
FDA issues a final rule that adds six bulk drug substances to its bulk substances listing that can be used by compounders not registered as outsourcin...
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notice: FDA determines that Schering-Plough Healthcare Products Lotrimin (clotrimazole) topical solution, 1%, was not withdrawn from ...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...