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Comments Sought on Device User Fee Forms

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on two FDA forms allowing applicants to certify that they qualify as a small business ...

FDA Said to Support Cost-based Labeling for Medimmune Vaccine

[ Price : $8.95]

FDA is brought in to reportedly support a cost-based effort by the American Academy of Pediatrics to constrain the approved labeli...

EU Reviewing Tysabri While Labeling Change is Underway

[ Price : $8.95]

European regulators say they have begun a risk-benefit review of Biogen Idec and Elans multiple sclerosis therapy Tysabri after 23...

President Signs $306 Million Budget Boost Into Law

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President Obama signs into law FDAs FY 2010 appropriations bill, which includes a $306 million (15%) boost in spending.

FDA Must Better Communicate Drug Info: Study

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Two researchers say that FDA must find a better way to communicate drug review information not included in labels to clinicians.

Comments Sought on Third Party Device Inspectors

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Federal Register Notice: FDA seeks comments on the publication of criteria that will be used to accredit third parties to conduct ...

Radiological Devices Panel to Meet

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Federal Register Notice: FDAs Radiological Devices Panel will meet 11/17-18 to discuss Full Field Digital Mammography Devices and ...

FDA Clears Collagen Dental Membrane

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FDA clears a Collagen Matrix 510(k) for its Collagen Dental Membrane intended for use in oral surgical procedures involving guided...