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FDA OKs Elixir Trial to Treat Heart Vessel Blockages
[163 Words]
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FDA grants IDE approval to Elixir Medical Corp. to begin patient enrollment in the EXCELLA III clinical trial to evaluate the DESyne NX Stent in 2,051 patients in the U.S.
05/08/2013
HHS OIG Updates Bulletin on Personnel Exclusions
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HHS Office of the Inspector General updates its 1999 special advisory bulletin on excluding persons from participating in federal healthcare programs.
05/08/2013
Pfizer Selling Viagra Online
[383 Words]
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Pfizer opens a Web site to sell Viagra directly to consumers holding a valid prescription.
05/08/2013
Merck BLA for Ragweed Pollen Tablet Accepted for Review
[148 Words]
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FDA accepts for review a Merck BLA for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet.
05/08/2013
Draft Aggregate Reporting Guidance Praised
[218 Words]
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Commenters voice support for FDA’s draft guidance on aggregate periodic reporting and ask specific questions for clarification.
05/08/2013
Hamburg Discusses Sequestration Effects at FDA
[238 Words]
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FDA commissioner Margaret Hamburg says she is still worried that sequestration funding cuts will compromise that agency’s regulatory activities.
05/08/2013
FDA Supporting Antibacterial Drug Development
[164 Words]
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FDA’s Antibacterial Drug Development Task Force works with stakeholders through CTTI to improve clinical study quality and efficiency.
05/08/2013
Maquet Cardio Class 1 Recall on Ventilator Battery Modules
[104 Words]
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Maquet Cardiovascular begins a Class 1 recall of the Maquet Getinge Group battery modules for use with the Maquet Servo-i ventilator systems.
05/08/2013
FDA Says Sterility Not Assured in Compounding Shop Drugs
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FDA says compounded sterile drugs from The Compounding Shop shouldn’t be administered to patients because sterility cannot be assured.
05/08/2013
Pew Likes Antibacterial Data Bill
[323 Words]
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The Pew Charitable Trusts urges quick passage of Senate legislation requiring FDA to collect and publish more information on animal antibiotic use.
05/08/2013
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