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TriLipix Review Time Extended

[ Price : $8.95]

FDA says it needs more time to complete review of Abbotts TriLipix for use in treating unhealthy lipid levels.

Correction Made to Animal Feed Rule

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Federal Register Final rule: FDA corrects dollar amounts in a 4/25 final rule that prohibited use of certain cattle origin materia...

No Pattern to Gardasil Serious Adverse Events

[ Price : $8.95]

CDC says there is no indication that reports of serious and non-serious adverse events associated with Gardasil vaccination are ca...

FDA Reports Serious Complications with Surgical Mesh

[ Price : $8.95]

FDA reports over 1,000 reports of serious complications with transvaginal placement of surgical mesh in repairing pelvic organ pro...

FDA Sends e-Submission Info to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a draft guidance on providing regulatory submissions ...

Acomplia Being Pulled in Europe

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Sanofi-Aventis says it will temporarily withdraw its obesity drug Acomplia from the European market due to psychiatric side effect...

Issues Arise Over Petition Changes

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Attorney Kurt Karst raises questions about FDAs implementation of new legal provisions on citizens petitions submitted regarding s...

Advisors Back Mass-produced Myozyme

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An FDA advisory committee recommends approval mass-produced Myozyme so long as the sponsor performs post-marketing safety and effi...

FDA Lifts Some Boston Scientific Restrictions

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FDA says it will lift some restrictions imposed on Boston Scientific products.