[ 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 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]
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...[ Price : $8.95]
FDA's Circulatory System Devices Panel recommends approval of Cook Medical's Zilver PTX Drug-Eluting Stent for treating peripheral...[ Price : $8.95]
Device industry negotiators dismiss FDA's recent user fee proposal that would have allocated funding for device reviewer retention...[ Price : $8.95]
An FDA safety alert seeks to reduce surgical fires in operating rooms.