Category: Regulations
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FDA Approves Viral Load Test for Organ Transplant Patients
The U.S. Food and Drug Administration today approved the first DNA test to gauge anti-viral treatments with solid organ transplant patients in cytomegalovirus (CMV) antiviral therapy. The COBAS AmpliPrep/COBAS TaqMan CMV Test was is marketed by Roche Molecular Systems in Pleasanton, California. CMV is a common virus that can cause severe diseases such as pneumonia…
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Trial Shows Platelet Drug Benefit for Aplastic Anemia
A clinical trial has shown eltrombopag, a drug originally designed to stimulate production of platelets from bone marrow, can raise blood cell levels in some people with severe aplastic anemia, who have failed all standard therapies. The findings of the phase 2 trial conducted by the National Heart, Lung, and Blood Institute (NHLBI), and other…
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UN Body Releases New Food Safety Standards
The UN’s Codex Alimentarius Commission issued new safety standards for infant formula, fruit, and seafood, as well as recommendations for nutritional labeling. The commission, a joint standards body of the UN’s Food and Agriculture Organization (FAO) and the World Health Organization (WHO), released the standards at its 2-7 July meeting in Rome. Codex standards can…
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iPhone App Developed for Adult Immunization Schedules
The American College of Physicians (ACP) in Philadelphia has released an application for the iPhone and iPad that provides clinicians with the latest guidance on vaccines for their patients. The free app, for which no Android version is yet available, was written for ACP by medical systems developer Cientis Technologies and Web app designer Hot…
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Study: Better Placebo Info Needed for Drug Trials
An analysis of pamphlets used to inform patients in clinical trials about the studies in which they take part indicates the literature short-changes discussion of placebos, in favor of the treatments being tested. The findings of health researchers led by psychology professor Felicity Bishop (pictured right) at University of Southampton in the U.K. appear in…
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Oracle Unveils Internet-Based Clinical Trial Services
The global software company Oracle has revealed two new Internet cloud-based services aimed at improving clinical trial design and recruitment. The services are expected to be announced today at DIA 2012, a medical products industry meeting in Philadelphia. Oracle says the two applications — Health Sciences Protocol Validator and Health Sciences Patient Recruiter — will…
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FDA Approves Drug to Manage Spinal Cord Injury Pain
Pfizer Inc. in New York says the U.S. Food and Drug Administration (FDA) has approved its drug pregabalin, marketed as Lyrica, to manage neuropathic pain associated with spinal cord injury. The drug was given a priority review by FDA. Spinal cord injuries can happen to young, healthy people as a result of trauma from car…
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NC State, Strasbourg Institutes to Advance Biomanufacturing
North Carolina State University in Durham and University of Strasbourg in France, along with the Alsace BioValley cluster in Europe, are forming Biomanufacturing Training and Education Center (BTEC) International, to provide educational and regulatory advisory services in the U.S. and Europe. BTEC International will initially combine the resources of NC State’s Golden LEAF Biomanufacturing Training…
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Nanomaterials Registry Begun for Health, Environment Queries
RTI International in North Carolina has started the Nanomaterial Registry, a Web-based database and resource of biological and environmental information on materials developed through nanotechnology. The registry, available free to the public, is funded by three agencies of National Institutes of Health: National Institute of Biomedical Imaging and Bioengineering, National Institute of Environmental Health Sciences,…
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Prescription Warning Label Effectiveness Found Limited
A study by researchers at Michigan State and Kansas State universities has found warning labels on prescription drugs have limited effectiveness due in large part to their inability to get the attention of users. The results of the study appear this week in the online journal PLoS One. The team led by Michigan State packaging…