Worthen D M, Boucher J A, Buxton J, Lowther G, Talbott M
Ophthalmology. 1981 May;88(5):381-5. doi: 10.1016/s0161-6420(81)35014-3.
Intraocular lenses have been regulated by the Bureau of Devices of the Food and Drug Administration since February 9, 1978. One year ago, data were reported through August 9, 1979, at which time more than 177,000 lenses of four different classes had been implanted. In the meantime, appeals and legal action by the Public Citizens Health Research Group of Washington, DC, have resulted in a re-examination of the intraocular lens issue and the FDA study of the lenses, which has resulted in a delay in any premarket approval, and prohibits the public release of the results of the study to date. This sequence of interesting interactions between physicians, manufacturers, the Food and Drug Administration, and a "consumer" group is outlined.
自1978年2月9日起,人工晶状体由食品药品监督管理局器械局监管。一年前,报告的数据截至1979年8月9日,当时已植入了超过17.7万枚四种不同类型的晶状体。与此同时,华盛顿特区公众公民健康研究小组提出的上诉和法律行动导致对人工晶状体问题及食品药品监督管理局对晶状体的研究进行重新审查,这导致任何上市前批准的延迟,并禁止公布迄今为止的研究结果。概述了医生、制造商、食品药品监督管理局和一个“消费者”团体之间这一系列有趣的互动情况。