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FDA to Appeal Neurontin Generics Orphan Exclusivity Order by Court

[ Price : $8.95]

FDA notifies the DC federal district court that it will appeal a 9/5 court order granting Depomeds motion for summary judgment com...

FDA Asked to End Ranbaxy ANDA Exclusivity

[ Price : $8.95]

An OFW Law client tells FDA it supports a petition asking the agency to rule that Ranbaxy has lost its 180-day exclusivity for sev...

Advisors Asked to Assess Farydak Risk/Benefit

[ Price : $8.95]

FDA asks members of its Oncologic Drugs Advisory Committee to weigh the benefits of Novartis Farydak in patients with relapsed mul...

Hospira Class 1 Recall of Infusion Pump Power Supply

[ Price : $8.95]

Hospira begins a Class 1 recall of its GemStar Power Supply, 3VDC, due to performance issues.

Regulatory Science and Review Enhancement MAPP

[ Price : $8.95]

CDER issues a MAPP on the Office of Translational Sciences management of the regulatory science and review enhancement program.

UFI System Specification Guidance

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An FDA guidance says the agencys preferred unique facility identifier for domestic and foreign drug establishments is the Data Uni...

FDA Denies Sodium Nitrate Standards Petition

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FDA denies a Hope Pharmaceuticals petition asking that companies filing NDAs or ANDAs for sodium nitrate or sodium thiosulfate dru...

New Mexico Physician Guilty Plea on Misbranded Drugs

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Deming, NM oncologist Mohamed Basel Aswad enters a guilty plea on charges he caused the unlawful introduction of misbranded drugs ...

FDA OKs Ranbaxy Generic Antara

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FDA approves Ranbaxy Laboratories fenofibrate capsules USP, 43 mg and 130 mg, a generic of Lupins Antara for treating high cholest...

Drug Companies Need to Change Mobile App Approach: Attorney

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Attorney Vinay Bhupathy says drug companies need to take a new approach if they are to successfully promote their mobile apps.