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Report Identifies New HIV Cases In Central Florida; County Official Discusses Findings
An annual report by the Health Council of East Central Florida released on Wednesday said that nearly 800 new cases of HIV were reported in Central Florida in 2008 and blacks and Hispanics remain disproportionately affected, the Orlando Sentinel reports. The report was presented to the Ryan White Planning Council, according to the Sentinel. The report said that there are now more than 4,000 people living with HIV in the area, and another 4,400 living with AIDS. In addition, a majority of the new cases of HIV were among blacks and Hispanics, according to the report (Maza, 7/29). In an interview with the Sentinel, Debbie Tucci, the Orange County Health Department"s HIV/AIDS program coordinator, discussed the findings. She said, "HIV/AIDS is not in the forefront the way it used to be. We"ve been talking about this for a long time, and people just don"t think it"s going to happen to them." She added, "The disease doesn"t care what your race or ethnicity is. Now we target minorities more, and what"s happened is that they"re getting tested more. Prevention strategies are absolutely working. There"s always room for improvement, but we"ve come a long way - especially among minorities" (Maza, 7/30).
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FDA Approval For Cetirizine Hydrochloride Tablets (OTC) ANDA - Hay Fever And Other Respiratory Allergies
Taro Pharmaceutical Industries Ltd. reported that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride tablets (OTC), 5 mg and 10 mg ("Cetirizine Tablets"). The product will be marketed by Taro"s U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.
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Rural Doctors To Invite PM On Rural Health 'fact Finding' Tour, Australia
The Rural Doctors Association of Australia (RDAA) will write to Prime Minister Kevin Rudd this week to invite him to participate in a national "fact finding" tour of rural hospitals, rural practices, health centres and Aboriginal Medical Services.
Diagnostics

Designer Of The World's First Hand-Held, Non-Contact Vein Illumination Device Meets Stringent ISO 13485 Safety, Design And Distribution Standards

AccuVein LLC, maker of the AV300, the world"s first hand-held, non-contact vein illumination device, announced that its quality system has received an International Organization for Standardization (ISO) 13485 Certification. This certifies to customers around the globe AccuVein"s commitment to the quality and safety of its medical device design, development, production, installation and delivery procedures. The quality system was further designed to meet U.S. FDA Good Manufacturing Practices (cGMP) requirements. AccuVein has begun shipping the AV300 in the U.S. and recently announced agreements with two large group purchasing organizations. In addition the AV300 is available on the General Services Administration Schedule, bringing the AccuVein AV300 to blood centers, hospitals, and government-affiliated institutions across the nation. "AccuVein launched the AV300 to help healthcare professionals locate hard-to-find veins and is committed to ensuring its products are of the highest quality while meeting healthcare provider and patient needs," said Stephen P. Conlon, President of AccuVein. "Receipt of this approval from BSI, an objective and accredited organization, is a critical step forward in our path to deliver the AV300 to healthcare practitioners around the globe." To achieve this three-year certification, AccuVein had to demonstrate that their quality system conforms to the exacting customer and regulatory standards of the ISO. ISO 13485:2003 is specifically designed for regulatory compliance of medical device companies. It supplements ISO 9001 with additional requirements including process control, design control, retention of records, accountability, traceability, and customer satisfaction. AccuVein achieved this key milestone following a careful assessment of their quality management system by BSI Group, a global provider of management systems assessment, certification and training services, with more than 60,000 certified locations and clients in over 100 countries. AccuVein"s quality system meets ISO standard and U.S. FDA Good Manufacturing Practices requirements. For a copy of AccuVein"s ISO 13485:2003 certificate, please visit http://www.AccuVein.com/quality. AccuVein


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