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- W144249210 abstract "A scheme of postmarketing surveillance (PMS) of IUDs is presented that offers a systematic and comprehensive approach to detecting changes in event rates and the incidence of rare but serious events at the earliest stage after a new IUD is marketed. A comprehensive PMS scheme would require IUD surveillance and IUD investigational studies including a centralized IUD computer data bank with information on premarketing clinical trials and follow-up of trial subjects; information on the overall prevalence of IUD use from projected national health sample surveys, manufacturers, and physicians; information on total incidence of rare events from a separate survey of physicians at least once every 5 years; and reporting by a network of stations of events in addition to pregnancy, expulsion, and removals for bleeding and pain. Whenever the risk of a rare IUD-related event appears to be unacceptable, an investigational study may be implemented to confirm the preliminary alert. Retrospective case-control studies, prospective studies, or historical prospective studies could be used to estimate increased risks of IUD use. Establishing an autonomous center to collect and monitor data on the comparative performance of both established and newly marketed IUDs could complement present activities of the US Food and Drug Administration (FDA). If a comprehensive system proved its ability to detect adverse effects of IUD use early, the FDA might shift its present emphasis on premarketing studies to postmarketing surveillance. Present surveillance costs to the FDA and the pharmaceutical companies could be reduced by relying on the proposed cooperative effort." @default.
- W144249210 created "2016-06-24" @default.
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- W144249210 date "1983-01-01" @default.
- W144249210 modified "2023-09-23" @default.
- W144249210 title "Postmarketing surveillance of IUDs." @default.
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