FDA clears a MiRus 510(k) for the MoRe-based Europa Pedicle Screw System, which the company says is the first cleared medical device with this new cla...
FDA warns the iMedDo Web site that it is selling unapproved and misbranded human and animal drugs.
FDA approves a Clarus Therapeutics NDA for Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogon...
FDA clears an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia...
FDA warns Thibiant International about CGMP violations in its production of finished pharmaceuticals.
Janssen Pharmaceutical files a supplemental BLA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethaso...
Federal Register notice: FDA seeks comments on an information collection extension for Clinical Laboratory Improvement Amendments (CLIA) of 1988 waive...
Federal Register notice: FDA makes available a final guidance entitled Standards Development and the Use of Standards in Regulatory Submissions Review...