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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Compliance Guide on Vacuum Switches Withdrawn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.

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...

OMB Approves Info on Electronic Products

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on general requirements for...

OMB OKs Info on Prohibited Animal Feed Substances

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on substances prohibited fr...

Annual Guidance Agenda Released

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Federal Register Notice: FDA publishes its annual guidance document agenda and seeks input on possible future topics.

Compliance Guide on Lasers Withdrawn

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Federal Register Notice: FDA withdraws an obsolete compliance policy guide on lasers as medical devices for facelift, wrinkle remo...