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FDA approves a Medtronic PMA for its CapSureFix Novus MRI SureScan 5076 Lead for use with magnetic resonance imaging.[ Price : $8.95]
CDER director Janet Woodcock says the review of biosimilar applications is straining agency resources.[ Price : $8.95]
FDA posts a final guidance on Distinguishing Medical Device Recalls from Medical Device Enhancements.[ Price : $8.95]
FDAs Los Angeles District Office warns Alpha Medical Instruments about Quality System violations in its manufacturing of angiograp...[ Price : $8.95]
FDA warns Chinas Beijing Shunxin Meihua Bio-technical Co. that it must permit FDA inspection of its facility that produces crude h...[ Price : $8.95]
FDA says it wants to survey pharmacists and patients about their experiences dealing with changes in generic drug appearance.[ Price : $8.95]
FDA clears a Clinical Innovations (Salt Lake City) 510(k) for its Koala Toco, a tocodynamometer that is designed to utilize air-ch...[ Price : $8.95]
FDA says it wants data from an upcoming trial before it can consider removing a boxed warning on Pfizers smoking cessation drug Ch...