Word: fda
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...industry where bigger is definitely better, the two behemoths seemed an ideal match. Expensive medical technologies like genetic engineering, combined with tougher FDA requirements, have made the cost of developing a single drug between $400 and $600 million -- about four times what it was 20 years ago. A combined Glaxo and SmithKline could have sunk $3 billion into research and development, compared to $1.8 billion for Novartis AG and $1.5 billion each for Merck & Co. and Pfizer...
...would be easy to dismiss the Hong Kong Incident as just a one-time quirk of blood and protein. But the U.S.'s leading flu experts seem unwilling to do so. This became particularly apparent at the annual meeting of the FDA Vaccine Advisory Panel, convened two weeks ago in Bethesda, Md., to decide what flu strains should be targeted for next year's flu vaccine. Ordinarily these meetings are routine, if not downright boring. But this year the committee devoted half the day to the Hong Kong outbreak...
...moment--the first time he had ever been invited to the meeting, a point he made clear in the opening moments of his talk. Equally striking, no one on the panel tried to minimize the potential danger of the new avian virus. Far from it. In a vote the FDA had not even requested, the committee unanimously agreed to move ahead to develop a vaccine against H5, even take it through clinical trials...
...human cloning controversy was touched off by maverick physicist Richard Seed and his plans for a clone clinic. Now FDA investigators are tracking down Seed to remind him that federal regulations require him to apply for agency approval...
...area. For doctors James Robl and Steven Stice and all the boys at the Ultimate Genetics ranch, however, cloning is a matter of fact. While cloned calves Charlie and George don't have human genes in their milk, Robl and Stice say the next ones will. Perhaps the FDA's beef should really be with these guys...