Word: fda
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Dates: during 1980-1989
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...reports prompted an investigation by the FDA. Last week Carnation , announced that it will no longer include the "hypoallergenic" label on its product. Furthermore, it will add a warning that milk-allergic babies, who constitute about 2% of the infant population, should take the formula only under a doctor's supervision...
...move is a major departure from the FDA's traditional practice of requiring rigorous tests, which can take up to seven years, to establish a drug's safety and effectiveness before granting approval. Black-market versions of the aerosol pentamidine have circulated for years, but the treatment has been studied in controlled clinical tests only since July 1987. The change of policy came after organized protests by AIDS patients, who argued that the Government's stringent regulations were blocking access to potentially lifesaving medicines...
Schooley said the new drug will probably notgarner FDA approval for several more years...
Working in affiliation with three other scientists around the country, Assistant Professor of Medicine Robert T. Schooley and his colleagues concluded in an article published this month in the Annals of Internal Medicine that ddC, which in many ways resembles the FDA-approved AZT, deters the replication of the AIDS virus in humans...
...think women should be warned that the safety of oral contraceptives is in question. "It's not clear the Pill is not associated with breast cancer," contended Judy Norsigian of Boston's Women's Health Book Collective. But most scientists, including those who conducted the disturbing studies, backed the FDA's stance. Said Bruce Stadel, an agency epidemiologist: "The findings are inconsistent and difficult to reconcile with biological plausibility...