This guidance document provides detailed information recommended for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers.

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Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills.

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Researchers at Wayne State University have tested a breast cancer vaccine they say completely eliminated HER2-positive tumors in mice - even cancers resistant to current anti-HER2 therapy - without any toxicity.

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Gastric acid suppression by proton pump inhibitors (PPIs) is associated with an increased risk of Clostridium difficile-related diarrhea in hospitalized patients, results of a case-control study indicate.
Reuters Health Information

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Cephalon Inc said on Monday that U.S. regulators will not allow it to market its painkiller Fentora for anyone other than cancer patients until the company implements enhancements to the drug’s risk management program.
Reuters Health Information

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The new add-on treatment for partial-onset seizures is expected to be available in US pharmacies the end of September.
Medscape Medical News

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Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the malignant melanoma drug market, driven by the launch of emerging agents, will experience robust annual 12 percent growth through 2012 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

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Children with epilepsy who were treated with a ketogenic diet versus the usual treatment of adrenocorticotropic hormone had good resolution of spasms and fewer adverse effects.
Medscape Medical News

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A study shows that vegetable and fruit intake is inversely related to colorectal cancer risk in men but not in women; the association appears stronger for colon than for rectal cancer.
Medscape Medical News

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Dermoscopy may help distinguish melanoma lacking significant pigment from benign lesions, though its diagnostic accuracy in these cases is inferior to that of more pigmented lesions.
Medscape Medical News

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