Word: fda
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...FDA's action is a victory for feminist health leaders, who initiated the decade-long campaign to approve the cap. Cervical covers date back more than 2,500 years, and have been made from materials as varied as opium, gold and ivory. Dr. Friedrich Wilde, a German gynecologist, developed the modern rubber version in 1838, and it quickly gained widespread popularity in Europe. In the U.S., however, it never caught on, mainly because Margaret Sanger, a pioneer in family planning in the 1900s, favored the diaphragm...
...interest in the cap revived in 1977 with publication of Women and the Crisis in Sex Hormones, by Barbara Seaman and Dr. Gideon Seaman, which contains a brief chapter extolling the merits of the cervical cap. The women's self-help movement began pushing for the contraceptive, but the FDA, citing a 1976 law regulating medical devices, ruled that it would have to undergo testing for safety and efficacy. More than 40,000 women ultimately took part in the stringent and lengthy trials...
...must use birth control while on it. The warnings, it seems, have not been enough. Some researchers at the Food and Drug Administration fear that the widely used drug could have caused between 900 and 1,300 babies to be born with severe birth defects, including brain damage. The FDA's concerns became public last week after the New York Times obtained a confidential agency report that raised the possibility of taking Accutane off the market...
...taken it are women. There is no doubt that Accutane can cause birth defects, says its manufacturer, Roche Laboratories of Nutley, N.J. But Roche has received reports of only 61 malformed infants born to women who have taken the drug, and the company sharply disputes the figures in the FDA memo. Says Roche Spokeswoman Carolyn Glynn: "The data are grossly exaggerated." An FDA representative acknowledges that Roche's tally is correct and that the 900 to 1,300 figures are projections, not official figures. The internal report containing them was originally meant to be discussed this week, when FDA...
...that the company used new lab techniques he had suggested to build on that 23-year-old discovery and isolate lovastatin, which could inhibit the production of melavonic acid and block the buildup of cholesterol. Merck spent eight years assessing lovastatin's safety. By November 1986, when Merck sought FDA approval for what was then known as MK- 803, agency officials were already familiar with the details, because the company had kept them informed of the drug's progress every step of the way. FDA approval last August came after just nine months of review, instead of the usual...