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Synthes and Norian Plead Guilty to Unauthorized Device Tests

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Synthes and Norian formally enter guilty pleas to charges involving unauthorized clinical tests of two bone cement products.

Reviewers Have Questions on Expanded Lap-Band Indication

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FDA reviewers ask the Gastroenterology and Urology Devices Advisory Panel to comment on whether Allergan has demonstrated the prac...

Shire Plans NDA Resubmission for Firazyr

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Shire says it plans to resubmit early next year an NDA that was rejected by the agency in 2008 for Firazyr (icatibant), indicated ...

FDA 'Complete Response' for Valeant Seizure Drug

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FDA issues Valeant Pharmaceuticals a complete response letter for an NDA for Potiga (ezogabine), an investigational anti-epileptic...

Advisors to Weigh Vandetanib Toxicity

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee whether a proposed indication for AstraZenecas vandetanib should ...

FDA Clears X-spine Fusion System

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FDA clears an X-spine 510(k) for the AXLE Interspinous Fusion System, intended for use in providing spinal stability for lumbar fu...

Optimer Pharma NDA for New Antibiotic

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Optimer Pharmaceuticals files an NDA for fidaxomicin, indicated for treating patients with clostridium difficile infection.

Onus is on Firms, FDA for Credible Social Media Info: Report

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A New England Journal of Medicine report says FDA and industry each should be responsible for the credibility of drug and device i...

FDA Expands Program on Medical Product Safety

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Federal Register Notice: FDA plans to expand its Conference Cooperative Agreement Program, awarded to the Brookings Institution to...

JAMA Study on OTC Labeling Finds Inconsistencies

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A new study reported online in the Journal of the American Medical Association finds high levels of variability and inconsistency ...