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Advisors Back New Crestor Indication

[ Price : $8.95]

Members of FDAs Endocrinologic and Metabolic Drugs Advisory Committee vote 12-4-1 to recommend approval of an expanded indication ...

FDA OKs Intervet Bovine Treatment

[ Price : $8.95]

Federal Register Final rule: FDA approves an Intervet, Inc. supplemental NADA to add Mycoplasma bovis as a pathogen for which flor...

Medicines Co. Recalls 11 Lots of Cleviprex

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The Medicines Co. recalls 11 lots of Cleviprex (clevidipine butyrate) injectable emulsion due to the potential presence of visible...

Jazz Pharmaceuticals NDA for Fibromyalgia

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Jazz Pharmaceuticals submits an NDA for JZP-6 (sodium oxybate oral solution), indicated for treating fibromyalgia.

Elan Pulls 2 Doses from Phase 2 Alzheimer Drug Trial

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Elan halts trials of an investigational Alzheimers drug at the two highest dose levels being studied.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Advanced Medical Optics, Craig Buettner, Endotec, Freeman Mfg, Huaiyin Medical I...

Quality System Violations Found at Endotec

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FDAs Florida District Office warns Endotec of numerous Quality System and corrective action reporting violations at its facility t...

Court Rejects FDA Affiliate Interpretation for User Fee Waiver

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An Illinois federal court rejects FDAs interpretation of the word affiliate in determining that it does not have to grant an NDA f...

Spinal Restoration and FDA Agree on Trial Details

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Spinal Restoration and FDA reach agreement on a Special Protocol Assessment for the design of a Phase 3 study involving the Biosta...

FDA Detaining Swedish Ophthalmic Viscoelastic Devices

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FDA says it is detaining without physical examination Advanced Medical Optics Uppsala Abs Healon D ophthalmic viscoelastic devices...