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FDA Approves HeartWare Ventricular Assist System

[ Price : $8.95]

FDA approves a HeartWare PMA for its HeartWare Ventricular Assist System, a left ventricular assist device intended for use to sup...

FDA, Dietary Supplement Maker Enter Consent Decree

[ Price : $8.95]

A federal judge in Minnesota approves a consent decree between FDA and Pharmacists Ultimate Health for unlawfully distributing una...

FDA Grants Fast Track for Hemophilia A Therapy

[ Price : $8.95]

FDA grants Inspiration Biopharmaceuticals fast track status for OBI-1 in acquired hemophilia A.

Quality System Violations Found at Integra NeuroSciences

[ Price : $8.95]

FDA warns Integra NeuroSciences about Quality System violations in its Hampshire , England, medical device manufacturing facility.

LapBand Marketing is Misleading, FDA Says

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FDA warns another California company about misleading promotion of the Lap Band gastric banding system.

Astellas sNDA for Tarceva in Lung Cancer

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Astellas Pharma files a supplemental NDA for Tarceva tablets for first-line treatment in patients with locally advanced or metasta...

FDA Publishes Electronic Data Guidance

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FDA publishes a guidance on electronic source data in clinical investigations.

Momenta Continuing Enoxaparin Sodium Suit

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Momenta says it will ask the Supreme Court to hear its case against Amphastar for using a Momenta patented method in producing a g...

FDA Approves Cell-cultured Flucelvax for Flu

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FDA approves the first seasonal flu vaccine using cultured animal cells rather than fertilized chicken eggs.

Guidance On Electronic Source Data in Clinical Investigations

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Federal Register Notice: FDA releases a draft guidance, Electronic Source Data in Clinical Investigations.