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A just-released CDRH letter warns baby product makers to not claim their devices prevent or reduce the risk of Sudden Infant Death...[ Price : $8.95]
FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes 17 to 0 to not recommend approval of Teva's Azilect (ras...[ Price : $8.95]
Vivus resubmits an NDA for its Qnexa (phentermine/topiramate) obesity drug that proposes a narrower indication than previously sou...[ Price : $8.95]
FDA clears a Medtronic 510(k) for its Aquamantys 3 System and its 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pie...[ Price : $8.95]
FDA clears an ALR Technologies 510(k) for its Health-e-Connect (HeC) System for remote patient monitoring in diabetes management p...[ Price : $8.95]
FDA clears a BioHelix 510(k) for the IsoAmp HSV Assay, which is intended for use in detecting Herpes Simplex Virus (HSV1 & HSV2).[ Price : $8.95]
A journal article by CDER deputy director for clinical science Robert Temple discusses the challenges of obtaining reliable compar...[ Price : $8.95]
Federal Register Proposed rule: FDA proposes to reclassify the external pacemaker pulse generator preamendments Class 3 device int...