Word: fda
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...worked," said Joe Tarnowski, CellPro senior V.P. "Doing the separations later gave us a second level of purging." With a "compassionate use" waiver from the FDA, the procedure was ready for testing. "Rick was the guinea pig," says Tarnowski...
...states that could give the industry broad legal shelter in return for a possible payment of as much as $300 billion over the next 25 years. The talks, which began about two weeks ago, may bring concessions long considered unthinkable by the tobacco industry: accepting some regulation by the FDA, disclosing the hundreds of chemical additives in cigarettes, and banning outdoor advertising and the use of people in ads. Why, after nearly four decades of successfully fighting off lawsuits, would big tobacco rather settle than fight? A deal makes sound business sense, notes TIME Wall Street Columnist Daniel Kadlec...
...course, the government has not been unaware of the increase in under-age smokers lighting up, nor has it been silent in response. The FDA cracked down on cigarette billboards near schools and on cigarette ads in magazines with youth readerships. But there is only so much a single agency can do against tobacco companies that have a total advertising budget of $5 billion. If the states joined the battle, tobacco companies could be shut out of the youth market de facto, as they already are de jure...
...certain to join in. And companies face more than a dozen private class-action suits and hundreds of individual lawsuits. At the same time, cigarette makers--minus Liggett--will soon troop to court in Greensboro, North Carolina, to hear a judge's decision on whether to allow new fda rules that say tobacco billboards must be at least 1,000 ft. from schools and that require young smokers to show photo...
They got some incentive two weeks ago, when the FDA approved for the first time the use of two protease inhibitors for children--Agouron's nelfinavir and Abbott's ritonavir. But parents and pediatricians complain that they still don't have enough information about how to use them. Nelfinavir, in particular, "went through the approval process very rapidly," says Dr. Mark Kline, associate professor of pediatrics at Baylor College of Medicine in Houston. "There are some basic pieces of information about nelfinavir that we don't have--like how often to give the drug or in what dose...