Category: Regulations
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FDA Approves First Treatment for Scorpion Stings
The Food and Drug Administration approved Anascorp, the first specific treatment for a sting by Centruroides scorpions, commonly known as the Arizona Bark Scorpion in the United States. The drug was developed by Rare Disease Therapeutics Inc. in Franklin, Tennessee, licensing research by University of Arizona in Tucson and and two research institutes in Mexico.…
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Nanotech Coating Helps Reduce Flames in Polyurethane Foam
Researchers from National Institute of Standards and Technology (NIST) and Texas A&M University in College Station have developed carbon nanofiber-filled coatings that outperform conventional flame retardants used in the polyurethane foam found in upholstered furniture and mattresses. Their findings appear in a recent issue of the journal Polymer (paid subscription required). Ignition of soft furnishings…
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Study: Computer Detection No Aid in Finding Breast Tumors
A group of university, research institute, and National Cancer Institute researchers have concluded that computer-aided detection (CAD) technology, often used with mammograms, is ineffective in finding breast tumors. The research indicates that CAD may also increase a woman’s risk of being called back needlessly for additional testing following mammography. The study, published online in the…
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FDA Alerting Pharmas Over Work of Contract Research Company [UPDATED]
The Food and Drug Administration has notified pharmaceutical companies that hired contract research organization Cetero Research of Houston, Texas that the work done by Cetero may need to be redone or confirmed. The alert to pharmaceutical companies follows an FDA letter sent yesterday to Cetero identifying problems in the company’s research, including falsification of entries…
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FDA Outlines Regulatory Science Needs for Drug Evaluations
The Food and Drug Administration published its proposed needs for regulatory science in the agency’s Center for Drug Evaluation and Research (CDER), its main drug regulating division. The document is available for public review and comments, which close 60 days following the 21 July 2011 publication. CDER regulates over-the-counter and prescription drugs, including biological therapeutics…
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FDA Approves Blood Thinning Drug for Heart Disease
The Food and Drug Administration approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). Brilinta is a product of AstraZeneca in Wilmington, Delaware. Brilinta helps prevent the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk…
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University to Study Fracking and Methane in Drinking Water
Researchers at Temple University in Philadelphia will investigate the origins of methane gas found in drinking water wells near Marcellus Shale drilling sites in Pennsylvania. A related research project will study the extent to which science influences public policy on shale gas drilling. Both studies are funded by a one-year, $66,000 grant from the William…
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FDA Issues Draft Guidance on Mobile Medical Phone Apps
The U.S. Food and Drug Administration today issued a draft of guidance to industry on oversight of mobile medical applications (apps) designed for smartphones and other mobile computing devices. Interested parties have 90 days to comment on the proposed regulations. The industry market analysts Research2Guidance expect as many as 500 million smartphone users worldwide will…
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Mercury Found in Soil Near Central Indiana Coal Power Plants
A study by researchers at Indiana University-Purdue University Indianapolis found that measurable amounts of mercury emitted by coal-fired power plants are deposited in central Indiana soil and can subsequently enter regional watersheds. The findings by earth scientists Carrie Lynne Hatcher (now at University of Toronto) and Gabriel Filippelli appear in the journal Water, Air, and…
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Council Recommends Steps for Home Medical Devices, Health IT
The National Research Council has recommended a series of actions to meet the likely increased demand for home use of medical devices and health information technology. The study was sponsored by the Agency for Healthcare Research and Quality (AHRQ), a division of the Department of Health and Human Services. The 11 recommendations for other agencies…