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Grassley Wants More Info on FDA Handling of Scientist

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Senate Finance Committee chairman Chuck Grassley asks FDA for more information on an internal investigation of a CVM scientist and...

FDA OKs Urinary Incontinence Implant

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FDA approves an Uroplasty, Inc. PMA for its Macroplastique implant, indicated for treating female stress urinary incontinence.

Public Meeting on NDC Changes

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Federal Register Proposed rule: FDA plans a public meeting to discuss the proposed changes to the National Drug Code system 12/11 ...

Info on Detention and Banned Devices Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on administrative detention and banned medical devices t...

Comments Sought on Device Small Business Certification

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Federal Register Notice: FDA seeks comments on a collection of information that will permit an applicant to certify that it qualif...

Info on IDE Reports Sent to OMB

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Federal Register Notice: FDA submits its proposed collection of information on investigational device exemptions reports and recor...

Comments Sought on Biologic Deviations

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Federal Register Notice: FDA seeks comments on information collection requirements on reporting of biological product deviations i...

Info on Xenotransplantation Sent to OMB

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Federal Register Notice: FDAs proposed collection of information on infectious disease issues in xenotransplantation has been subm...

BMS, Sanofi-Aventis Sued Over Plavix Safety

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A class action lawsuit claims Bristol-Myers Squibb and Sanofi-Aventis aggressively promoted Plavix despite being aware of serious ...

Larenz Tate in Sickle Cell Campaign

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Movie actor Larenz Tate is working with Novartis on a blood sickle education campaign to tell people about the risk of iron overlo...