Suppr超能文献

人工晶状体最新报告。

Update report on intraocular lenses.

作者信息

Worthen D M, Boucher J A, Buxton J, Lowther G, Talbott M

出版信息

Ophthalmology. 1981 May;88(5):381-5. doi: 10.1016/s0161-6420(81)35014-3.

Abstract

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.

摘要

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。

相似文献

1
Update report on intraocular lenses.人工晶状体最新报告。
Ophthalmology. 1981 May;88(5):381-5. doi: 10.1016/s0161-6420(81)35014-3.
2
Interim FDA report on intraocular lenses.
Ophthalmology. 1980 Apr;87(4):267-71. doi: 10.1016/s0161-6420(80)35239-1.
3
FDA to inspect AIDS "buyers' clubs".
Am J Hosp Pharm. 1992 Feb;49(2):257.
4
The FDA report on intraocular lenses.
Ophthalmology. 1983 Apr;90(4):311-17. doi: 10.1016/s0161-6420(83)34555-3.
6
Status of toric intraocular lenses.散光人工晶状体的现状。
Curr Opin Ophthalmol. 2007 Feb;18(1):58-61. doi: 10.1097/ICU.0b013e328011f9bf.
8
FDA study of intraocular lenses.
Ophthalmology. 1983 Apr;90(4):45A-46A. doi: 10.1016/s0161-6420(83)34543-7.

引用本文的文献

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验