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Quality System Violations Found at Integra NeuroSciences

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Federal Register Notice: FDA releases a draft guidance, Electronic Source Data in Clinical Investigations.

Panel to Discuss NDAs for Airflow Obstruction and Cystic Fibrosis

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 1/29-30/13 to discuss a Boehringer Ingelheims S...

FDA Still Has Workforce, Management Challenges: Report

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A Partnership for Public Service report says FDA continues to experience workforce and management challenges in keeping up with me...

Guidance on IRB Responsibilities

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FDA issues a draft guidance to remind IRBs about their responsibilities in clinical investigator qualifications, research site ade...