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FDAs Atlanta District Office warns bioMerieux about Quality System violations in its Durham, NC, diagnostic device manufacturing f...[ Price : $8.95]
FDA warns Lancome USA that many products sold through its Web site are considered drugs that dont have agency approval.[ Price : $8.95]
FDA issues a complete response letter for Navidea Biopharmaceuticals Lymphoseek NDA.[ Price : $8.95]
FDA unveils a new, agency developed and manufactured hand-held device, employing LED technology, for rapid identification of count...[ Price : $8.95]
FDA clears a Precision Spine 510(k) for the Slimplicity Solo Anterior Cervical Plate System for use in cervical spine procedures.[ Price : $8.95]
Geron stops a randomized Phase 2 study involving imetelstat in metastatic HER2-negative breast cancer because median progression-f...[ Price : $8.95]
FDA clears an Abiomed, Inc. 510(k) application for the Impella CP, a percutaneous catheter-based heart pump.[ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to withdraw four NADAs that are no longer marketed.