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FDA Clears Life Spine Long Bow Interbody System

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the Long Bow Expandable Lateral Interbody System.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Brava and West Coast Laboratories.

Fast Track for MedImmune Anti-pneumonia Biologic

[ Price : $8.95]

FDA grants MedImmune a fast track designation for its investigational monoclonal antibody MEDI3902 for preventing nosocomial pneum...

FDA Approves, Denies Parts of Generic Estrace Petition

[ Price : $8.95]

FDA says it will require a clinical endpoint study including an analysis of adverse events for ANDAs citing Warner Chilcotts Estra...

Custom Device Exemption Guidance Out

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FDA issues a guidance on its implementation of the revised custom device exemption from the FDA Safety and Innovation Act.

Amgen Files BLA for Blinatumomab in Leukemia

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Amgen files a BLA for blinatumomab, seeking approval for the investigational bispecific T cell engager (BiTE) antibody construct f...

FDA Approves Gore Viabahn Endoprosthesis for In-stent Restenosis

[ Price : $8.95]

FDA approves a W. L. Gore & Associates PMA for its Viabahn Endoprosthesis for interventional treatment of in-stent restenosis in t...

FDA Submits Collection of Info on Qualitative Feedback to OMB

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Federal Register Notice: FDA submits a proposed collection of information on generic clearance for the collection of qualitative f...

Revised Guidance on Estradiol Vaginal Cream

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Federal Register Notice: FDA releases a revised draft guidance document on bioequivalence recommendations to support ANDAs for est...

Panel to Discuss InterSpinous Spacer Device

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Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 12/12 to discuss a Vertiflex PMA for the Super...