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...attempts to assess the merit of the doctors' charges have been inconclusive. An FDA investigation in August found that two out of 17 poultry samples from Puerto Rico were "suspect for estrogenic activity." Despite this, says FDA District Director Lynn Campbell, the analysis "has uncovered no evidence of the unlawful use or abuse of estrogen or hormone-like compounds...
...these safety features is prohibitively expensive. Aluminum seals cost 2? apiece at most, and the machine used to attach them to bottles sells for only $9,000. But it could be three or four months before the drug industry can gear up to produce new containers. Even then, as FDA Commissioner Hayes notes, none of the methods is foolproof. Packaging experts admit, for example, that a careful criminal with a razor blade and a bit of glue could remove and replace an aluminum seal seemingly intact...
...years and many doctors later, Dr. Melvin Van Woert of New York City's Mount Sinai Hospital identified the condition that ended her career: myoclonus, a nervous disorder that affects only 2,000 Americans. Van Woert had received a series of grants and special permission from the FDA to treat the disease with the experimental drug L-5HTP (L5-hydroxy-tryptophan), and Dobkin responded well to it. Within eight months she was able to walk with crutches and a neck brace and begin training for a new career as a medical assistant. Eventually she was well enough to have...
...syndrome, and researchers like Van Woert. A study by the committee identified 134 drugs to treat orphan diseases, but found that only 58 were on the market or even under investigation by drug manufacturers. Furthermore, more than two-thirds of the orphan products that have been approved by the FDA over the past decade were developed with the help of Government or university funding. Says Subcommittee Chairman Henry Waxman: "That's an unhappy commentary on industry effort...
...legislation. In fact, the Administration issued a position paper last week opposing the measure. The statutory creation of an interagency orphan-products board, the Administration said, was superfluous be cause an equivalent panel existed within HHS. Waxman had already altered the bill to accommodate earlier Administration objections. Both the FDA and the Pharmaceutical Manufacturers Association had opposed a provision in the original bill that would have permitted approval of orphan drugs after one successful human clinical trial. With that provision dropped and other changes made, the P.M.A. now supports the bill, though it continues to defend its past record...