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Amerisource Bergen Settles Cancer Drug Charges for $625 Million

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The Justice Department says Amerisource Bergen is paying $625 million to resolve three whistleblower suits claiming that it operat...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Datascope Corp. and Sofie Biosciences.

Acessa Health Fibroid Device Cleared

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FDA clears an Acessa Health 510(k) for the Acessa ProVu System, an integrated radiofrequency ablation, ultrasound visualization, a...

Endo Recalls Robaxin Due to Labeling Error

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Endo International recalls two lots of Robaxin (methocarbamol tablets, USP) 750mg tablets in 100-count bottle packs due to some pr...

FDA Warns About Dosing Errors with Compounded Injectables

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FDA says it has received reports of dosing errors and confusion with the labeled strength expression for certain compounded inject...

Draft Guide on Human Factors Submissions

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Federal Register notice: FDA releases a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human...

Draft Guide on Adaptive Trial Designs

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Federal Register notice: FDA makes available a draft guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics...

Draft Guide on Master Protocol Trial Designs

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Federal Register notice: FDA makes available a draft guide entitled Master Protocols: Efficient Clinical Trial Design Strategies t...

Oscor Recalls TB Bipolar Pacing Leads

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Oscor Inc. recalls its TB Temporary Bipolar Pacing Lead (unshrouded 2 mm Pins Models) due to connectivity concerns.

Ventana Class 1 Recall of Detection Kits

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Ventana Medical Systems recalls (Class 1) multiple detection kits due to a potential for false negative results caused by reagent ...