Word: fda
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Dates: during 1990-1999
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...ambiguous evidence, a jury ordered Merrell Dow to pay a Texas couple $33.8 million; they claimed the antinausea drug Bendectin had maimed their child in the womb. And patients around the country are lining up to sue Eli Lilly, alleging that the anti-depressant Prozac induces violent thoughts -- despite FDA findings to the contrary. In some cases, companies decide to settle out of court rather than take their chances with juries. Upjohn, for example, paid an undisclosed sum to a woman who claimed the drug Halcion had driven her to commit murder. Most doctors believe the allegation is absurd...
...Wolfe just crying wolf? Or has a pervasive corruption -- which the FDA seems powerless to stop -- spread throughout the pharmaceutical and medical- device industries? Upjohn and Dow Corning strenuously deny any wrongdoing.They point out, rightly, that only a small proportion of consumers report problems with their products, and that it is naive to expect perfection in so large and complex a business. In the U.S. alone, there are 3,000 types of drugs on the market and more than 1.5 billion prescriptions written every year. A small number of incidents with a handful of drugs is hardly an indictment...
...read scores of Dow Corning documents, including 17 internal memos dating as far back as the mid-1970s, about silicone-gel breast implants. The information surfaced during a liability suit in Michigan. When he finished, Anderson wrote and hand-delivered both the documents and an urgent letter to the FDA demanding that all such implants be promptly removed from the marketplace. "This appeal is not made lightly," Anderson wrote. He noted that Dow Corning officials had assured an FDA review panel, of which Anderson was a member, that the company had disclosed all relevant information on implants...
...resulting furor rattled the FDA like no scandal since the thalidomide scare of the early 1960s. Following Anderson's appeal, the agency declared a moratorium on all silicone-gel implants, pending further review. "It's the ultimate case as to why you need a strong agency," says FDA Commissioner David Kessler. Now, says Kessler, "the honor system is out the window." He promises that companies will be subject to intensive audits in which investigators will scrutinize how data are analyzed and presented by the manufacturers. Says he: "People have to know that we have the will and resolve to deal...
...female condom, a polyurethane pouch which is inserted into the vaginal canal, received an FDA recommendation for marketing approval pending the fulfillment of several conditions. These include the completion of a pregnancy prevention study, development of a more accurate direction insert and further testing of used condoms for tears and leakage...