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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...

FDA Grants Octapharma Fast Track for Octaplex

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FDA grants Octapharma USA fast track status on its investigational drug Octaplex as a treatment for reversing anticoagulation ther...

FDA Patient Focus Urged to Improve Drug Safe Use

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Workshop participants looking at how health literacy can promote safer drug use say FDA needs to take a more active role in a numb...

FDA Clears Quests Simplexa Flu Test

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FDA clears Quest Diagnostics Simplexa molecular flu test.

CDRH Head Dismisses 'Flawed' Study on Device Delays

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CDRH director Jeffrey Shuren dismisses a recent study on device approval delays, calling it highly flawed with its inadequate samp...

California Stem Cell Files IND for Spinal Muscular Atrophy

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California Stem Cell files an IND with FDA to begin a Phase 1 safety study for a stem cell-derived therapy to treat Spinal Muscula...

FDA Approves New Cubicin Dosing

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FDA approves a shorter dosing time for Cubicin for treating MRSA.