Word: fda
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Dates: during 1980-1989
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Food and Drugs. The Food and Drug Administration has long been considered overly cautious about approving new drugs, even when doctors, drug manufacturers and patients were urging fast action. The Reagan Administration set out to make the FDA move faster. Now some critics charge that the FDA has become a tool of the drug industry. They cite the FDA's approval in 1982 of Oraflex, an arthritis pain reliever, despite evidence that its side effects might be highly toxic. In the first three weeks, 64,000 U.S. prescriptions were written. But after 61 deaths in Britain had been linked...
...from a friend enabled Vorhauer to begin clinical testing in Mexico City in 1977. But when the money ran out, Vorhauer was hard-pressed to keep his company afloat. He recalls one point when he had just $3.50 in the bank. During his seven-year wait for FDA approval, he was inspired by the inscription on a statue of Buddha that stands on his desk: "Those who cannot wait never...
...clinical tests of more than 2,000 women conducted in the U.S. and six foreign countries during the past four years report that the sponge drew few complaints from users. Says Dr. Richard Soderstrom, a partner in the Mason Clinic in Seattle who is also a member of the FDA panel on toxic shock: "There are no systemic side effects, and no risk of infection...
...specifically addressed the risk of toxic shock, since some research indicates that barrier devices like the diaphragm may encourage the development of the bacteria believed to cause the deadly illness; Soderstrom reports that the spermicide in the sponge seems to kill the bacteria. Nevertheless, as an added safeguard, the FDA will require a label advising women to remove the sponge within 24 hours to reduce that risk. This is a bonus for V.L.I. Initially the company planned to advertise Today as a 48-hour protection. Before it even hits the shelves, the potential market has doubled...
...mother took the synthetic hormone diethylstilbestrol during her pregnancy. As a DES daughter, I hope that FDA Commissioner Arthur Hayes will not approve the use of Depo-Provera until long-term studies of its safety have" been made. We should not give rise, as we did with DES, to another generation of "clinical studies," but should prudently await definitive studies on Depo-Provera's safety...