Consumer Information on: Medtronic® Attain StarFix™ Model 4195 Lead - P060039

Published in July 10th, 2008

Posted by CDRH Consumer News in Medical Devices and Radiological Health

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The Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over..

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves; Availability.

Published in July 10th, 2008

Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health

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This guidance document provides information to FDA staff and industry about FDA’s strategy for addressing further imports of surgeons’ and patient examination gloves (medical gloves) from manufacturers/shippers whose medical gloves have failed to meet…

Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Condoms; Availability.

Published in July 10th, 2008

Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health

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This guidance document provides information to FDA staff and industry about FDA’s strategy for addressing further imports of condoms from manufacturers/shippers whose condoms have failed to meet FDA’s minimum acceptable quality criteria.

Federal Register: Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability.

Published in July 10th, 2008

Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health

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These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices.

U.S. Measles Outbreak Hits 127 People in 15 States

Published in July 10th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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The biggest U.S. outbreak of measles since 1997 has affected 127 people in 15 states, most of whom were not vaccinated, federal health officials said on Wednesday.
Reuters Health Information

Risk of Gallbladder Disease Lower With Transdermal Rather Than Oral HRT

Published in July 10th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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No matter how hormone replacement therapy (HRT) is administered, it appears to increase the risk of gallbladder disease, but new research suggests that the risk is lower if HRT is given transdermally rather than orally.
Reuters Health Information

Intermittent Malaria Chemoprevention Improves Children’s Cognitive Function

Published in July 10th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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Results of a large field trial in Kenya indicate that a school-based program of intermittent preventive treatment of malaria reduces anemia and improves classroom attention in children.
Reuters Health Information

Denosumab Boosts Bone in Postmenopausal Women

Published in July 10th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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Twice yearly treatment with the investigational agent denosumab significantly increased bone mineral density (BMD) and reduced bone turnover markers in postmenopausal women with low BMD, researchers report in the June issue of the Journal of Clinical Endocrinology and Metabolism.
Reuters Health Information

Coolant Spray Reduces Pain in Children Undergoing Intravenous Cannulation

Published in July 10th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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Evaporation-induced skin cooling using a “vapocoolant” spray quickly reduces pain due to intravenous cannulation in children, according to findings published in the July 1st issue of the Canadian Medical Association Journal.
Reuters Health Information

Templeton Asset Management Rejects Sun Pharmaceutical’s Tender Offer for Taro Pharmaceutical

Published in July 10th, 2008

Posted by Drugs.com - Pharma News in Drugs and Food Information, Pharmaceutical Industry News

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SAN MATEO, Calif.–(BUSINESS WIRE)–Jul 10, 2008 - Templeton Asset
Management Ltd. (”Templeton Emerging Markets Team”) today rejected
Sun Pharmaceutical’s (”Sun”) tender offer for Taro Pharmaceutical
(”Taro”) shares. Mark Mobius, executive chairman…