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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 grants Octapharma USA fast track status on its investigational drug Octaplex as a treatment for reversing anticoagulation ther...[ Price : $8.95]
Workshop participants looking at how health literacy can promote safer drug use say FDA needs to take a more active role in a numb...[ Price : $8.95]
FDA clears Quest Diagnostics Simplexa molecular flu test.[ Price : $8.95]
CDRH director Jeffrey Shuren dismisses a recent study on device approval delays, calling it highly flawed with its inadequate samp...