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Nominations Sought for Science Board

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Federal Register Notice: FDA requests nominations to serve on the Science Board to the FDA.

Panel on Radionuclide Imaging for Alzheimers

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 10/23 to discuss radionucli...

Vaccine Preservative Reg Reviewed to End Thimerosol

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A CBER microbiolgist tells an advisory committee her Center is reviewing a vaccine regulation with a view to ending the use of thi...

Defibrillator Software Lead Fracture Update

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FDA approves a Medtronic software update that sounds an audible alert if it detects a fractured Sprint Fidelis lead.

Advisors to Consider Fablyn Deaths in Trials

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FDA tells the Reproductive Health Drugs Advisory Committee that Pfizers proposed post-menopausal osteoporosis drug Fablyn was asso...

FDA Fast Track for Celgene Lung Cancer Therapy

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FDA grants a fast track designation for Celgenes amrubicin, indicated for treating small cell lung cancer after first-line chemoth...

Off-label use of rhMBP Products Risks Health

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FDA cautions against use of recombinant human Bone Morphogenetic Protein (rhBMP) in the cervical spine.

MS Drug Gains Fast Track Designation

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FDA grants a fast track designation for BioMS Medicals dirucotide (MBP8298), indicated for treating secondary progressive multiple...

FDA Orders Increased Immunosuppressor Fungal Warnings

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FDA calls for labeling changes to immunosuppressant TNF alpha-blockers on the possibility of fungal infections in patients using t...

Biological Product Deviation Reports up 26%: CBER

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CBER Office of Compliance and Biologics Quality director Mary Malarkey says biological product deviation reports were up 26% last ...