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Vanda Agrees to Pay Over $11 Million in Off-label Suit

[ Price : $8.95]

Vanda Pharmaceuticals agrees to settle an off-label marketing case for $11.5 million.

Researcher Convicted in FDA False Statement Case

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A federal jury convicts former clinical researcher for making a false statement to a government investigator related to her role i...

DoJ Renews Individual Accountability Interest in Prosecutions

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The Department of Justice says its top priority for corporate criminal enforcement is individual accountability by targeting the i...

Pfizer Plans BLA for New Meningococcal Vaccine

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Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY).

FDA Panel to Discuss Kidney Disease Drug

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Federal Register notice: FDA announces an 11/16 advisory committee meeting to discuss an Ardelyx NDA for tenapanor hydrochloride t...

Heron Gets NDA Approved for Aponvie

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FDA approves a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea ...

ICH Guide on Elemental Impurities

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Federal Register notice: FDA releases a final guidance entitled Q3D(R2) Guideline for Elemental Impurities.

FDA Reminds on Endotracheal Tube Obstructions

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CDRH updates a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of ...

HHS Outlines FDA Projects Under Biotech Initiative

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HHS details specific FDA projects that will be undertaken as part of President Bidens recent Executive Order launching a National ...

3 Notices on Animal Minor Use/Major Species

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Federal Register notices: FDA publishes three notices about its most recent periodic reassessment of the definition of small numbe...