Word: fda
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...fast. The standard drug-approval process poses a problem, and Washington hopes to reduce the time and expense by simplifying the approval process for pharmaceuticals useful against bioterrorism. Because things like radiation poisoning or plague occur rarely, it's difficult to find human subjects to test new cures. The FDA has eased the rules for bioterrorism-related drugs, allowing tests for effectiveness to be conducted entirely on animals, though a human test to establish safety is still required...
...cochlear implant is a technological miracle that has restored hearing to thousands of children with severe to profound hearing loss. But according to a study conducted by the FDA and the CDC, children who receive implants are more than 30 times as likely to develop bacterial meningitis infections. These infections, even when treated with antibiotics, are lethal in some 10% of cases...
...years, doctors assumed that children, biochemically speaking, are little adults. So anytime they had to give a child a grownup medication, such as Prozac, they just lowered the dose on the basis of his or her weight. But in 1998 the FDA ruled that companies had to conduct pediatric tests of adult drugs. That rule followed a 1997 law offering drugmakers a six-month extension on their patents if they did so voluntarily...
Still, two conservative groups sued the FDA, arguing that Congress hadn't given the agency the authority to require such tests, and in October 2002 a federal judge agreed. Last week the Senate, in a unanimous voice vote, moved to reverse that decision, passing a bill allowing the FDA once again to require the tests. The rare show of bipartisan unity on a health-care issue bodes well for the nation's children: the measure now moves to the House carrying emphatic FDA support. --By Eric Roston
...FDA officials did not respond to repeated requests for comment...