Category: Regulations
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Survey: Public Wants Informed Consent for Biobanks
A survey and focus groups on public attitudes toward informed consent for participation in collections of tissue samples, show a preference for giving consent in advance, balanced with convenience for the contributors. The findings from researchers at the University of Iowa College of Medicine appear in the online issue of the journal Genetics in Medicine…
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Trial Tests Heart Valve Replacement Without Opening Chest
A clinical trial at several medical centers in the U.S., including Rush University Medical Center in Chicago, is testing a new approach for implanting an aortic heart valve without open-heart surgery. This technology is designed for patients with conditions such as severe aortic stenosis — constriction of the left heart ventricle — who are considered…
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Neuromuscular Drug Gets Fast-Track, Orphan Approval
Repligen Corp. in Waltham, Massachusetts says its drug candidate for spinal muscular atrophy received fast-track and orphan drug status from U.S. and European regulators. The U.S. Food and Drug Administration (FDA) granted fast-track status to Repligen’s RG3039, while the European Medicines Agency gave the drug its orphan medicinal product designation. Spinal muscular atrophy (SMA) is…
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Head Injuries Decline After Bicycle Helmets Mandated
Investigators at University of New South Wales (UNSW) in Sydney, Australia report that bicycle-related head injuries fell significantly in the months after mandatory helmet legislation came into effect in that province. The researchers published their findings in the journal Accident Analysis and Prevention (paid subscription required). Australia was the first country to introduce mandatory helmet…
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Pain Killer with Built-in Abuse Deterrence Gets FDA Clearance
A prescription pain killing drug developed by Pfizer Inc. in New York and Acura Pharmaceuticals Inc. in Palatine, Illinois has received marketing approval from the U.S. Food and Drug Administration. Oxecta, an opioid analgesic tablet made from oxycodone hydrochloride (HCl), contains ingredients developed by Acura Pharmaceuticals to deter tampering that leads to misuse or abuse…
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Trial Shows Sealant Gel Closes Spinal Surgery Wounds
A clinical trial led by researchers at University of California at Davis found a gel that creates a watertight seal to close surgical wounds, sealed spinal wounds 100 percent of the time. The UC Davis team reported their findings in the online issue of the journal Spine (paid subscription required). The trial, funded by the…
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Calendar Blister Packs Shown to Help Medication Adherence
A study of drug packaging indicates that calendar blister packaging with days or dates printed on the card under the individual dose helps patients keep to the prescribed schedule for those drugs. The results of the study appeared in the May 2011 issue of the journal Clinical Therapeutics (paid subscription required). Poor medication adherence leads…
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FDA Approves Genetic Test for Breast Cancer Treatment
The Food and Drug Administration (FDA) approved a new genetic test that will help health care professionals determine if women with breast cancer are candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment. The Inform Dual ISH test is made by Ventana Medical Systems, a division of the Roche Group, in Tucson, Arizona. The…
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Wireless Security Devised for Implanted Medical Devices
Engineers at Massachusetts Institute of Technology in Cambridge and University of Massachusetts in Amherst have designed a system that shields implanted medical devices like heart pacemakers and defibrillators from unauthorized wireless access or sabotage. Their findings will be presented at the ACM Special Interest Group on Data Communication (SIGCOMM) conference in Toronto, Canada in August.…
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Lab Tests Indicate Inhaled Carbon Nanotubes Pose Cancer Risk
Researchers at University of Edinburgh in Scotland found some types carbon nanotubes could cause cancer if inhaled. Ken Donaldson, a toxicology professor at Edinburgh, and colleagues published their findings in the June 2011 issue of the American Journal of Pathology (paid subscription required). Carbon nanotubes are a type of nanoscale material (1 nanometer equals 1…