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Pediatric Panel to Discuss Safety Review

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Federal Register Notice: FDAs Pediatric Advisory Committee will meet 12/7 to discuss safety reviews for 13 products.

FDA Approves Avanir NDA for Laughing/Crying Episodes

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FDA approves a Avanir NDA for Neudexta (dextromethorphan hydrobromide and quinidine sulfate) for treating pseudobulbar affect, a ...

DSOB Updated on REMS and Safe Use

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CDER says the Drug Safety Oversight Board discussed REMS, Stalevo cardiovascular risk, and the Safe Use Initiative at its 9/16 mee...

Lesko to Receive Award for Drug Development Innovation

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FDA announces that FDA Office of Clinical Pharmacology Director Larry Lesko will receive the 2011 American Society for Clinical Ph...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Vita-Herb Nutriceuticals.

FDA Hearing on Biosimilars Presents Differing Views

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An FDA public meeting on biosimilars hears differing views on demonstrating biosimilarity and the potential interchangeability of ...

WLF Concerned About FDA Prosecution of Execs

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Washington Legal Foundation argues against HHS and FDA steps to prosecute corporate officers for company misdeeds they knew nothin...

FDA Looking to Jail Company Executives

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FDA litigation chief Eric Blumberg says the agency is looking for cases in which it can fine and jail drug company leaders for the...

Medtronic Recalls Tissue Stabilizers

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Medtronic recalls its Octopus Nuvo Tissue Stabilizer due to the potential for a device component fracture during use.

Why Did Tri Med Seizure Take 13 Years to Happen?

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Consulting editor John Scharmann reviews the 13-year history behind a recent FDA seizure of violative products at Tri Med Laborato...