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Synthes and Norian formally enter guilty pleas to charges involving unauthorized clinical tests of two bone cement products.[ Price : $8.95]
FDA reviewers ask the Gastroenterology and Urology Devices Advisory Panel to comment on whether Allergan has demonstrated the prac...[ Price : $8.95]
Shire says it plans to resubmit early next year an NDA that was rejected by the agency in 2008 for Firazyr (icatibant), indicated ...[ Price : $8.95]
FDA issues Valeant Pharmaceuticals a complete response letter for an NDA for Potiga (ezogabine), an investigational anti-epileptic...[ Price : $8.95]
FDA medical reviewers ask the Oncologic Drugs Advisory Committee whether a proposed indication for AstraZenecas vandetanib should ...[ Price : $8.95]
FDA clears an X-spine 510(k) for the AXLE Interspinous Fusion System, intended for use in providing spinal stability for lumbar fu...[ Price : $8.95]
Optimer Pharmaceuticals files an NDA for fidaxomicin, indicated for treating patients with clostridium difficile infection.[ Price : $8.95]
A New England Journal of Medicine report says FDA and industry each should be responsible for the credibility of drug and device i...