Word: fda
(lookup in dictionary)
(lookup stats)
Dates: all
Sort By: most recent first
(reverse)
...turnaround in thinking comes at a particularly crucial time, because pharmaceutical manufacturers are getting ready to launch a new group of anti- HIV drugs onto the fast track. Their success in doing so may hinge on the outcome of an FDA advisory-panel meeting that is taking place this week in Rockville, Maryland. Panel members are expected to consider the activists' criticisms and determine whether the agency's fast track has too many shortcuts in it and should be revamped yet again...
...consumer group has asked the FDA to ban prescription sales of a drug for nighttime leg cramps; the group says that quinine sulfate, while effective against malaria, is dangerous when used to treat cramps. An fda ban on over- the-counter brands will take effect in February...
...originally conceived, the fast-track process makes a lot of sense. The goal is to streamline the necessary steps toward FDA approval so that they do not take years to complete. One way to accomplish that, the agency decided, was to accept preliminary evidence from small clinical trials rather than wait for final proof from a comprehensive study. Typically the trials consist of a few hundred people and last only a matter of months. In return, the pharmaceutical companies were supposed to conduct follow-up studies that confirmed their drugs' effectiveness after they were out on the market. The FDA...
WASHINGTON -- Is nicotine a drug or not? Both Congress and the FDA need to know before they fire the next volley in the tobacco wars, and they are looking to science for guidance. Washington's prestigious Institute of Medicine will come to the rescue this week with a finding that nicotine is indeed addictive and should be regulated as a drug. But instead of a complete ban on cigarettes, the iom recommends raising the cigarette tax from 24 cents to a hefty $2 a pack...
...smoke bombs at the National Institutes of Health? If there was a single, unifying battle cry among protesters, it was the charge that the Federal Government's delays in approving experimental treatments were responsible for killing thousands of desperately ill AIDS patients. Now, a mere two years after the FDA relaxed some of its standards and established a "fast track" to rush drugs from the test tube to the bedside, a growing number of activists are changing their minds. "We were naive," admits Spencer Cox, of the New York City-based Treatment Action Group. "There are standards for a reason...