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Firms Paying $421 Million in False Claims Settlement

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Three drug companies agree to pay $421 million to settle whistleblower False Claims Act suits.

Compliance Guide on Vacuum Switches Withdrawn

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Federal Register Notice: FDA withdraws an obsolete compliance policy guide on the definition of high-voltage vacuum switch.

Advisors Recommend Contrave Approval

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Members of FDAs Endocrinologic and Metabolic Drugs Advisory Committee recommend that FDA approve Orexigens Contrave for weight los...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites OsteoSymbionics, Steris, and Vanderveer Center.

Inspection Sees CGMP Problems in Cranial Plate Implant Manufacture

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FDAs Cincinnati District Office warns OsteoSymbionics about CGMP violations at its cranial plate implant manufacturing facility.

Topaz Nearing NDA for Head Lice Treatment

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Topaz Pharmaceuticals says it plans a 2011 NDA submission for its ivermectin topical cream as a treatment for head lice.

FDA Releases Report on Graphic Cigarette Labeling

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Federal Register Notice: FDA adds a research study to the docket proposing required warnings and graphics on cigarette packages.

Comments Sought on Device Registration Requirements

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Federal Register Notice: FDA seeks comments on requirements for additional listing information for medical device registration.

FDA Clears Orthovita Bone Graft Substitute

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FDA clears an Orthovita 510(k) for its Vitoss Bioactive Foam-2X Bone Graft Substitute for use as a non-structural bone void filler...

Info on Adverse Event Pilot Program Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on an adverse event pilot program to the Office of Manag...