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Comments Sought on New Drug Applications

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Federal Register Notice: FDA seeks comments on Application for FDA Approval to Market a New Drug.

Akhigbe Debarred

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Federal Register Notice: FDA issues an order debarringn Ehigiator O. Akhigbe from providing services to a person with an approved ...

Public Citizen Analyzes Recent Pharma Settlements

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A new Public Citizen analysis finds a marked increase in both the number of government settlements with pharmaceutical companies a...

Elan, Eisai Paying for Off-label Zonegran Promotion

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The Justice Department says Elan and Esai and paying $214 million to resolve off-label promotion allegations involving Zonegran.

McNeil's GMP Troubles Continue to Grow

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A new FDA inspection report adds to the troubles facing McNeil Consumer Healthcare.

Court Upholds Purdue Executives Exclusion

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A DC federal judge upholds the exclusion of three Purdue Frederick executives from participating in federal healthcare programs fo...

Parallel Review Can Hurt Innovative Device Companies: MDMA

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MDMA says a FDA/CMS parallel review process could hurt patient care and innovation.

St. Jude Replaces Silicone ICD Leads with Optim Leads

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St. Jude Medical says it is phasing out its Riata and Riata ST family of defibrillation leads which use silicone as the outer insu...

FDA Seeking End to Avastin Breast Cancer Indication

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Under immediate House Republican denunciation, FDA recommends that the Avastin breast cancer indication be removed from labeling a...

Advisors Suggest a Partial Ban on Dental Amalgam

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Members of CDRHs dental advisory panel exceeding their mandate suggest banning use of dental amalgam in children.