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Nominations Sought for Tobacco Committee

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Federal Register Notice: FDA requests nominations for voting members for the Tobacco Products Scientific Advisory Committee.

FDA Fast Track for ALS Cell Therapy

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FDA grants BrainStorm Cell Therapeutics a fast track designation for NurOwn for treating amyotrophic lateral sclerosis.

Takeda Sues FDA, HHS Over Mitigare Approval

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Takeda asks the DC federal court to order FDA to rescind or stay its approval of a Hikma 505(b)(2) application for Mitigare.

CareFusion 203 Recalls Ventilators

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FDA says CareFusion 203 Inc. is recalling three ventilator models that can experience a loss of power.

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...