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A Jazz Pharmaceuticals citizen petition asks FDA not to approve any generic applications that reference its Xyrem (sodium oxybate)...[ Price : $8.95]
Emmaus Life Sciences files an NDA for its orally administered pharmaceutical grade L-glutamine (PGLG) for treating sickle cell dis...[ Price : $8.95]
FDA clears a Carestream 510(k) for the OnSight 3D Extremity System, which uses cone beam computed tomography technology to capture...[ Price : $8.95]
United Exchange Corp. recalls five lots of its Family Care Eye Wash due to microbial contamination.[ Price : $8.95]
FDA posts an International Conference on Harmonization draft guidance on General Principles for Planning and Design of Multi-Regio...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on postmarket surveillance to the Office of Management a...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on recordkeeping requirements in Medical Devices: Current Good Manufacturing Practice ...[ Price : $8.95]
Federal Register Notice: FDA renews the charter of the Oncologic Drugs Advisory Committee.