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Hispanics Dont Understand Atherosclerosis: Study

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An AstraZeneca-funded study shows that U.S. Hispanics have a lower awareness and understanding of atherosclerosis than of other he...

FDA Solicits Sunscreen Ingredient Info

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FDA requests safety and effectiveness information on ecamsule as a sunscreen ingredient.

FDA Hold on GVAX Prostate Cancer Trial

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FDA places a partial clinical hold on Cell Genesys terminated VITAL-2 GVAX prostate cancer immunotherapy program.

Allergan Planning Botox Migraine sBLA

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Allergan says it will file a Botox sBLA in 2009 for treating chronic migraine.

Black Box Warning on PML added to Rituxan

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Genentech and Biogen Idec revise the black box warning on Rituxan after a rheumatoid arthritis patient treated with the therapy de...

LifePak Defbrillators Recalled

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CDRH says Physio Control has recalled its LifePak CR automated external defibrillator.

Vanda Responding to FDA on Anti-psychotic

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Vanda Pharmaceuticals will give FDA a complete response to a non-approvable letter on its anti-psychotic iloperiodone.

FDA Clears St. Jude Medicals Confirm ICM

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FDA clears St. Jude Medicals Confirm implantable cardiac monitor.

Info on Radiopharmaceuticals Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on regulations for in vivo radiopharmaceuticals used for d...

Globalization Impacts FDAs Operating Centers

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Representatives of FDA operating Centers provide attendees at the 2008 PDA/FDA Joint Regulatory Conference (9/10) with updates on ...