Category: Regulations
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Clinical Trial Shows Drug Improves Heart Muscle Functions
A clinical trial conducted by University of Hull in the U.K. shows the drug omecamtiv mercabil improves the heart’s ability to pump blood in heart failure patients. The findings by Hull cardiology professor John Cleland and colleagues appear in the 20 August issue of the journal The Lancet (paid subscription required). Omecamtiv mercabil is one…
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Powder-Free Latex Gloves Reduces Latex Allergy Rate
Researchers at the Medical College of Wisconsin in Milwaukee have found that stopping the use of powdered latex gloves reduces allergic sensitization to latex among health care workers. The team’s findings appear online in the Journal of Occupational and Environmental Medicine (paid subscription required). Kevin Kelley, professor of pediatrics and internal medicine, led the Wisconsin…
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FDA Issues Regulatory Science Modernization Plan
The U.S. Food and Drug Administration today released its Strategic Plan for Regulatory Science that calls for modernization of the science used to protect the nation’s food and drug supplies. The plan describes the agency’s intent to improve the ways it develops and evaluates new products and materials, as well as improve the way it…
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First Flaw Reportedly Found in Advanced Encryption Standard
Computer scientists from European universities and Microsoft Research have found a weakness in the Advanced Encryption Standard (AES) algorithm. Andrey Bogdanov from Katholieke Universiteit Leuven in Belgium, Christian Rechberger from L’École Normale Supérieure in Paris, and Dmitry Khovratovich from Microsoft Research say that the discovered flaw makes the recovery of the secret AES encryption key…
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FDA Issues Draft Clinical Trial, Benefit-Risk Guidelines
The U.S. Food and Drug Administration has issued separate draft guidelines involving medical devices, one for designing better clinical trials, and the other for benefit-risk determinations. Both documents are open for public comment for 90 days. FDA’s guidance documents generally do not establish legal responsibilities, but instead describe FDA’s current thinking and recommendations. The clinical…
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Auto Crash Model Can Simulate Offshore Oil Pipe Breaks
Engineers at MIT have shown how a simulation model that tests automobile components for crashworthiness can be applied to predict the performance of pipes in offshore drilling accidents. The team from MIT’s Impact and Crashworthiness Laboratory presented their findings at the International Offshore and Polar Engineering Conference in June. Tomasz Wierzbicki, professor of applied mechanics…
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Fewer Drug-Resistant Bacteria in New Organic Poultry Farms
A study of mid-Atlantic poultry farms that switched to organic practices shows significantly lower levels of drug-resistant enterococci bacteria that can spread to humans. The findings by researchers from University of Maryland, Johns Hopkins University, and Pennsylvania State University appear online in the journal Environmental Health Perspectives. The research, led by Amy Sapkota with the…
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Banned Flame Retardants Found in Pregnant California Women
In a pilot study of pregnant women in California, researchers at University of California in San Francisco have found high levels of flame-retardant chemicals that have been outlawed in the U.S. and Europe. The team’s findings appear online in the journal Environmental Science and Technology (free registration required). The researchers, led by Tracey Woodruff, director…
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Better Building Codes Urged for Tornado, Hurricane Regions
Researchers and engineers from universities and industry that reviewed the damage caused by destructive Spring 2011 tornadoes in the U.S. call for more intensive engineering design and more rigorous, localized construction and inspection standards to reduce property damage and loss of life. The report of the group’s research on the Tuscaloosa, Alabama tornado on 27…
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More Antidepressants Prescribed for Non-Psychiatric Disorders
Researchers from Johns Hopkins University in Baltimore, Maryland and Columbia University in New York find that the rapid growth of prescriptions for antidepressant medications has been fueled by orders from non-psychiatrist providers and without any psychiatric diagnosis. The paper by Ramin Mojtabai of Johns Hopkins and Columbia’s Mark Olfson appears in the August 2011 issue…