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Lawyers Analyze SCOTUS Refusal to Hear FAC Cases

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Attorneys from two firms say the Supreme Courts refusal to hear appeals in two False Claims Act cases leaves open the question of ...

Senators Want FDA Action on DMBA

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Sens. Durbin and Blumenthal call on FDA to take action against designer stimulants like DMBA in dietary supplements.

Advisors Mixed on Boston Scientific Watchman

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FDA advisors vote that the Boston Scientific Watchman medical device has benefits that outweigh its risks, even though it may not ...

ICU Medical Recalls ConMed Flow Controller

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FDA says ICU Medical is recalling its ConMed Stat 2 flow controller.

Pharmaceutical Innovations to Fight FDA Injunction

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Sued last week by FDA for a permanent injunction over its unapproved accessory gels for use with ultrasound and other devices, Pha...

Groups Want Health IT Legislation

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Sixty organizations ask Congress to pass laws implementing FDA recommendations for a risk-based approach to oversight of health in...

Guidance on Vet Med Adverse Event Terms

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CVM issues a final harmonized guidance on terms for use in reporting animal medicine adverse events.

FDA Speeding Medical Device Reviews: Hamburg

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FDA commissioner Margaret Hamburg says her agency is developing ways to speed promising medical devices through a robust regulator...

Consolidated BIMO Program Under Consideration at FDA

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FDAs Program Alignment directive aims to re-shape bioresearch monitoring (BIMO) inspections by creating a dedicated corps of ORA s...

Stronger Chantix Label Sought

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Five consumer and medical advocacy organizations call on FDA to strengthen safety warnings in the Chantix labeling.