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FDA Grants Pharmalink an Orphan Drug Designation

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FDA grants Pharmalink an orphan drug designation for Busulipo, a conditioning agent for use in cancer patients prior to hematopoie...

QS Violations in King Systems Inspection

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FDAs Detroit District Office warns King Systems about Quality System Regulation violations in its manufacturing of breathing circu...

Hepatitis C Drug Development Guidance Out

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FDA issues a draft guidance to help sponsors plan clinical development of direct-acting antiviral drugs for treating hepatitis C.

FDA Approves Afaxys Generic Contraceptive

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FDA approves an Afaxys Pharmaceuticals ANDA for contraceptive Aubra (levonorgestrel and ethinyl estradiol tablets, USP 0.1mg/0.02m...

Court Reasoning Flawed in Infuse Preemption Case: Attorney

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Attorney Matthew Reed says an Arizona federal court contradicted itself in ruling that a state law claim against Medtronics Infuse...

FDA Clears iTraumaCare Expanded Indication

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FDA clears an iTraumaCare expanded indication for its iTClamp Hemorrhage Control System to include the temporary control of severe...

FDA Clears EndoChoice Fuse Gastroscope

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FDA clears an EndoChoice 510(k) for its new Fuse Gastroscope that has a field of view of 245 degrees.

Expanded Indication Approved for Lundbecks Sabril

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FDA approves Lundbecks Sabril (vigabatrin) as add-on therapy for treating refractory complex partial seizures in children aged 10 ...

FDA Denies it Promised Not to OK Abusable Opioids

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FDA contradicts a claim by a congressman that assured him it would not approve new opioids unless they had abuse-deterrent formula...

Info on Premarket Notification Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on premarket notification to the Office of Management a...