Research Compliance
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No More Clinical Trials?
May 11, 2012A clinical investigator in Florida suggests that clinical trial simulators could someday replace trials with real participants – at least to some extent. In an interview with MedCity News, Dr. Michael Smith explained that supercomputers could be used to conduct virtual trials involving many thousands of subjects, analyzing realistic data to predict outcomes at relatively [...]
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FDA Expands Scope of Clinical Investigator Disqualification
May 7, 2012FDA recently published a final rule amending 21 CFR 16, 312, 511 and 812. Under the new rule, which will become effective on May 30, 2012, a determination that a clinical investigator is ineligible to receive one kind of test article will automatically disqualify that individual from receiving other types of test articles, and from [...]
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Primer on Nanotechnology
May 7, 2012The Congressional Research Service has released a report entitled, “Nanotechnology: A Policy Primer“. Detailed within are current areas of nanotechnology product research and development (with examples from private and public research) and funding for these programs. The funding levels by fiscal year are available in table format, showing an increasing trend of funding. Public attitudes, broken down [...]
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FDA approves treatment for plague without clinical trial data
April 30, 2012The FDA has approved Levaquin (levofloxacin)(Johnson & Johnson’s) for the treatment of pneumonic plague (caused by Yersinia pestis). A member of the fluoroquinolone family of drugs, it is currently approved for treatment of numerous infections, including post-inhalation Anthrax exposure. The approval was not based on human efficacy trials, however, but was approved under the agency’s Animal Efficacy [...]
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The Forest Service’s 83 Experimental Forests and Ranges
April 30, 2012The Forest Service (USDA) operates 83 Experimental Forests and Ranges (who knew?) where intensive scientific study is undertaken to map diverse ecological sites. Among the many goals of their work, the Forest Service aims to 1. Develop of systems for managing and restoring forests, rangelands, and watersheds; 2. investigate the workings of forest and stream [...]
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