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Court Upholds Preemption in Incretin Therapies Case

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A California federal court says plaintiffs claims that four diabetes drug manufacturers should have included a label warning about...

FDA Clears 2 New Hitachi Scenaria Models

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FDA clears two Hitachi Medical Systems America Scenaria models of CT scanners.

Forest Asks High Court to Hear Namenda Case

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Forest Laboratories asks the Supreme Court to hear and reverse a 2nd Circuit Appeals Court decision that requires it to continue m...

Panel to Discuss IMPROVE-IT Statins Trial

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FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/14 to discuss the results of the IMPROVE-IT trial, which ...

WLF Wants High Court to Hear OTC Preemption Case

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Washington Legal Foundation and the Allied Educational Foundation urge the Supreme Court to hear an OTC ibuprofen labeling case to...

MDUFA 4 Stakeholders Want More Diverse Trials

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Stakeholders meeting with FDA on MDUFA 4 reauthorization say there should be more population diversity in medical device clinical ...

FDA Clears Kator Suture Anchor System

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FDA clears a Kator 510(k) for the Kator Suture Anchor System for use in tissue-to-bone reattachment.

FDA Approves Perrigo ANDA for Generic KlorCon

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FDA approves a Perrigo ANDA for a generic version of Upsher-Smith Laboratories KlorCon (potassium chloride) extended-release table...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Biomedic Labs Johnson Memorial Cancer Center, and Orgen Nutraceuticals.

Senate Hearing on Califfs Nomination Set for 11/17

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The Senate Health, Education, Labor and Pensions Committee sets an 11/17 hearing to review the nomination of FDA deputy commission...