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QS Violations Found at Cagenix

[ Price : $8.95]

FDAs New Orleans District Office warns Cagenix about Quality System violations in its manufacturing of dental bridge frameworks.

Exelixis Starting Prostate Cancer Phase 3 Cabozantinib Trial

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Exelixis says it will start a Phase 3 trial of cabozantinib for treating castration-resistant prostate cancer.

State Law Backing FDA Preemption Hurts Consumers, Industry

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Michigan resident Henry Greenspan urges Wisconsin not to approve a law preventing consumer state tort suits alleging that FDA-appr...

Comments Extended on Food/Animal Feed Facility Controls

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Federal Register Notice: FDA reopens the comment period on preventive controls for human food and animal food/feed facilities.

Mammography Panel Representatives Sought

[ Price : $8.95]

Federal Register Notice: FDA seeks participants in selecting representatives to serve on the National Mammography Quality Assuranc...

Nominations Sought for Device Panels

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Federal Register Notice: FDA requests both nominations and participants in the selection process for nonvoting industry representa...

Abbott's Next Generation Xience Stent Approved

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FDA approves Abbott's next-generation Xience Prime Everolimus-Eluting Coronary Stent System for treating coronary artery disease.

LDR Lumbar Fusion Device Cleared

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FDA clears an LDR 510(k) for the ROI-A Oblique ALIF cage and its use in lumbar fusion surgery.

Somaxon Seeks Restrictions on Generic Silenor ANDAs

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Somaxon asks FDA not to approve ANDAs for generic Silenor than dont meet bioequivalence requirements sought by the company.

Info on Veterinary Feed Directive Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the veterinary feed directive to the Office of Manage...