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FDA Safety Alert for Anzemet Injection

[ Price : $8.95]

A new FDA drug safety alert says Sanofi-Aventis Anzemet (dolasetron mesylate injection) should no longer be used to prevent nausea...

FDA Approves Medtronic's Cardiac CryoAblation System

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FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for use in treating drug refractory paroxysmal atrial f...

FDA Seeks More Data Analysis on AstraZeneca's Brilinta

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FDA sends AstraZeneca a complete response letter on its NDA for Brilinta (ticagrelor), requesting an additional analysis of clinic...

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.