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FDA Proposes Informed Consent Exceptions for Emergencies FDAnews
- Saturday, September 02, 2006 The FDA may be making life easier for researchers conducting studies in emergency settings when patients are unable to give their informed consent, issuing a draft guidance on informed consent exceptions Aug.
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Inspection Uncovers Mold Growth, Leads to Warning Letter FDAnews
- Saturday, September 02, 2006 An in vitro diagnostic manufacturer failed to investigate root causes of nonconformances, including fungus and mold growth, the FDA said in a recent warning
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FDA Cites Inadequate Examination Procedure for Blade System FDAnews
- Saturday, September 02, 2006 An inspection of Medisurg Research & Management’s facilities led to a warning letter regarding the Fugo Blade System, a battery-operated cutting apparatus used for capsulotomy, glaucoma and peripheral
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Informed Consent Form Problems Lead to Warning Letter FDAnews
- Saturday, September 02, 2006 Failure to obtain informed consent and schedule required follow-up visits with device clinical trial subjects led to a warning letter for clinical investigator Barry Eppley of the Riley Hospital for Children,
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Third-Party Audit Leads to Stricter Regulation Enforcement FDAnews
- Saturday, September 02, 2006 Regulation violations including improper audit procedures prompted the FDA to issue a warning letter to Sonotech, an ultrasound gel
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Cardinal Health Removes Pumps From Market After Seizure FDAnews
- Saturday, September 02, 2006 Cardinal Health Aug. 28 announced it had suspended production, sales, repairs and installations of its Alaris SE infusion pump after the government seized approximately 1,300 of the devices Aug.
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Irish Device Group Seeks Small Business Status FDAnews
- Saturday, September 02, 2006 The Irish Medical Devices Association (IMDA), which falls within the Irish Business and Employers Confederation, has called for “a concerted effort to be made across Europe” to establish a system to enable small EU-based device and diagnostic companies to benefit from fee reductions when registering new product applications with the
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Briefs FDAnews
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Device Recalls FDAnews
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FDA PARTNERS WITH MIT TO DEVELOP DEVICE-TRACKING DATABASE FDAnews
- Saturday, September 02, 2006 The FDA is partnering with the Massachusetts Institute of Technology (MIT) to develop new databases to monitor devices and drugs after they have been
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CEPHEID WINS $3.3 MILLION NIAID GRANT TO DEVELOP RAPID TB TEST FDAnews
- Saturday, September 02, 2006 Cepheid said Aug. 30 it had won a $3.3 million grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop rapid detection technology for tuberculosis
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SAFETY ALERT ISSUED FOR MEDICAL EQUIPMENT CLEANING DEVICES FDAnews
- Saturday, September 02, 2006 The FDA and Steris have issued a MedWatch safety alert for two devices used to clean reusable medical
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MEDTRONIC DEVICE EFFECTIVE IN PARKINSON'S TRIAL FDAnews
- Saturday, September 02, 2006 Medtronic Inc.'s Activa brain stimulation device, combined with medication, improves motor functions and quality of life in patients with advanced Parkinson's disease more than in patients receiving only medication, according to a study published in Thursday's issue of the New England Journal of
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NEW DEVICE MAY IMPROVE VISION AND MOBILITY FOR PEOPLE WITH TUNNEL VISION FDAnews
- Saturday, September 02, 2006 Scientists at Schepens Eye Research Institute, an affiliate of Harvard Medical School, say a visual aid they invented promises to improve the visual abilities of people with tunnel
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GENETIC TESTING COMPANY STRIKES JAPAN DEAL FDAnews
- Saturday, September 02, 2006 A small Morrisville company that is working to make drugs safer in the U.S. is reaching out to Japan as a first step in strengthening its worldwide
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SMILING SYRINGES LESS THREATENING FDAnews
- Saturday, September 02, 2006 Smiley faces, fish, suns and many other stickers were used to decorate medical devices and reduce patients' fear of them, according to a study done by researchers at UNM's Health Sciences
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SEAT BELT TO PROTECT IMPLANTED MEDICAL DEVICES FDAnews
- Saturday, September 02, 2006 Pressure Products has launched the SoftTouch device for attaching to a seat belt to reduce impact forces over an implantable device when the wearer is in a vehicle
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FISH FATTY ACIDS MAY PREVENT MORE SUDDEN DEATHS THAN DEFIBRILLATORS FDAnews
- Saturday, September 02, 2006 Omega-3 fatty acids may prevent more sudden deaths than automated external defibrillators in homes and public places or implanted defibrillators, according to the results of a new
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Refugees Beginning Returning Home But Many Still Reluctant allAfrica.com
- Saturday, September 02, 2006 Nearly half of the 40,000 refugees who fled Togo during post-election violence last year have left refugee camps in Benin and Ghana, and the Togolese government says it plans to repatriate those
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Starlets Show Spark of Black Stars in Friendly allAfrica.com
- Saturday, September 02, 2006 The national Under-17 football team, the Black Starlets beat their Benin counterparts, US Seme KRAKE 3-1 in an international friendly match at the Sunyani Coronation Park on
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