Word: fda
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...humble soybean has been touted as a cure-all that fights cancer, eases menopause and does a whole lot more. The FDA even allows labels on soy products that say they "may reduce the risk of heart disease." But other claims are still in doubt. A new study of 200 women ages 60 to 75 found that a soy-protein powder was no better than a placebo in improving bone density, cognitive function or cholesterol levels. Don't give up tofu just yet, though. The results may not apply to younger women or other soy foods...
...FDA has approved NeutroSpec, a technique that could make it significantly easier to diagnose appendicitis. That's good news because accurate diagnosis is a problem. Half the 700,000 cases of suspected appendicitis in the U.S. each year lack the usual symptoms of fever and pain in the lower right abdomen, and 15% to 40% of all appendectomies prove unnecessary because the appendix turns out to be normal. The new technique uses a radioactive tracer that binds to an infection-fighting white blood cell. Doctors locate the tracer using an imaging device called a gamma camera. In trials, the technique...
Leeches, those ancient, creepy medical devices, have just been given a U.S. seal of approval. Though doctors have long used the little bloodsuckers to clear pooled blood in skin grafts and blocked veins, the French company Ricarimpex SAS is the first to have sought and received FDA clearance, under a 1976 law, to market the invertebrates for medicinal purposes. If that makes you squeamish, consider this: the FDA this year also allowed the marketing of medicinal maggots to eat away dead tissue from wounds...
...same medicine for less. But just for a moment, put yourself in the shoes of pharmaceutical executives who last week attended a conference in Boston on the latest practice to tarnish their trade: the sale and illegal marketing of drugs for "off label" uses not approved by the FDA. "Rarely has a conference been more timely," warned James Dillon, a partner at Foley Hoag, the Boston-based law firm that sponsored the event. Prosecutors and regulators are circling, the executives were told. Would-be whistle-blowers are collecting promotional materials, saving e-mails, taping phone calls--in the hope...
...there may be risks. The FDA issued a firm warning earlier this year in its consumer magazine. Although there are no reported cases of ultrasound causing harm to a fetus, the FDA SAYS we simply don't know enough about the long-term effects of repeatedly sending high doses of energy across a mother's womb. After all, these ultrasonic waves are the same as those used at higher exposure to break up kidney stones. Laboratory studies have shown that even at low levels, ultrasounds can produce physical effects in tissue, including jarring vibrations and temperature increases. John Hayes, editor...