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FDA urges medical product sponsors to use centralized methods for monitoring clinical studies conducted on their behalf.[ Price : $8.95]
FDA clears a Toshiba America Medical Systems 510(k) for the HDR-08A Imaging System with Kalare R&F technology.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, Oversight of Clinical Investigations: A Risk-based Approach to Monitoring.[ Price : $8.95]
FDA clears a Spine Wave 510(k) for the StaXx XDL Expandable Device, a PEEK (polyetheretherketone) spacer for use in spinal surgeri...[ Price : $8.95]
FDA sends Novartis a complete response letter on a BLA for Ilaris (canakinumab) and its use in gouty arthritis patients.[ Price : $8.95]
FDA approves a Janssen Pharmaceuticals NDA for Nucynta ER (tapentadol), an oral analgesic taken twice daily for managing moderate ...[ Price : $8.95]
FDA issues a safety alert on King International's 510(k)-exempt ShoulderFlex Massager based on reports submitted to the U.S. Consu...[ Price : $8.95]
FDA posts a hurricane preparedness checklist with preparations to maintain drugs, devices, food, and water in case of power outage...