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Is FDA Planning Court Action Against McNeil?

[ Price : $8.95]

Increased FDA pressure directed at Johnson & Johnson's McNeil drug unit could spell out a pending federal court action taking shap...

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.

FDA Panel Rejects Prostate Cancer Drugs

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Members of FDAs Oncologic Drugs Advisory Committee vote not to recommend expanding use of GlaxoSmithKlines Avodart (dutasteride) a...

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 ...