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FDA Grants Fast Track for MS Therapy

[ Price : $8.95]

FDA grants Opexa Therapeutics fast track status for tovaxin and its use in treating patients with secondary progressive multiple s...

Rothenberg Permanently Debarred

[ Price : $8.95]

Federal Register Notice: FDA issues an order permanently debarring Gayle Rothenberg from providing services to anyone with an appr...

Comments Extended on Device Modification Guidance

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Federal Register Notice: FDA reopens the comment on a draft guidance on 510(k) device modifications.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites International Isotopes and SterilMed.

CGMP Violations Found at International Isotopes

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FDAs Seattle District Office warns International Isotopes about CGMP problems in manufacturing a radiopharmaceutical and marketing...

Make Medical Device Approval Changes: Caucus

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Members of the Congressional Medical Technology Caucus ask FDA commissioner Margaret Hamburg to make four specific changes to the ...

FDA Clears Mobile Medical Image Viewer

[ Price : $8.95]

FDA clears a Carestream 510(k) for the Vue Motion medical image viewer and its use with mobile devices such as Apple iPads.

FDA Approves Expanded Indication for Erbitux

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FDA approves Bristol-Myers Squibbs Erbitux (cetuximab) for use with chemotherapy to treat patients with metastatic head and neck c...

FDA Clears Quidel Influenza A+B Immunoassay

[ Price : $8.95]

FDA clears a Quidel 510(k) for the Sofia analyzer and Sofia Influenza A+B Fluorescence Immunoassay.

Congress Should Overhaul FDA Review Process: Op-ed

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A Forbes op-ed says Congress should overhaul FDA's review processes when it takes up the user fee reauthorization early next year.