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【drug-news】FDA加强对上市药物的安全性评估
The U.S. Food and Drug Administration needs more staff and funding to fix its monitoring of drug safety after medicines are on the market, the Institute of Medicine (IOM) said on Friday.
The IOM, an independent group that studies scientific matters for the government, also suggested that drugs carry a "new drug" symbol during the first two years on the market to alert consumers that less is known about the risks and benefits.
Five years after a drug's launch, the FDA should conduct a formal review of all available information about the product's risks and benefits, the report also said.
The FDA requested the report in 2004 after the agency was criticized as being lax in its oversight of Merck & Co Inc.'s arthritis drug Vioxx and other medicines.
The authors said the FDA had taken steps to strengthen its post-approval system but "major obstacles" remained, including "a dysfunctional organizational culture, problems with credibility and public trust and the lack of adequate communication about, and limited public awareness of, drug risks and benefits."
The report also recommended a six-year term for the FDA commissioner to add stability to the agency. Now, the term is an open-ended appointment by the president. The agency has had a permanent head for just 18 months since President George W. Bush took office 5 years ago. 好不容易碰上一篇有机会认领，呵呵 翻译完毕，交稿，最后两段话，实在不知道怎么理解和翻译，请各位赐教！
The U.S. Food and Drug Administration needs more staff and funding to fix its monitoring of drug safety after medicines are on the market, the Institute of Medicine (IOM) said on Friday.
美国食品与药品管理局需要更多的人手和资金来实现其对已经上市的药品的安全监控，医学会在星期五提出。
The IOM, an independent group that studies scientific matters for the government, also suggested that drugs carry a "new drug" symbol during the first two years on the market to alert consumers that less is known about the risks and benefits.
医学会，一个为政府部门研究科学事务的独立组织，也建议在上市头两年的新药上贴有“新药”的标志，以提醒消费者关于此药的危险和益处还了解甚少。
Five years after a drug's launch, the FDA should conduct a formal review of all available information about the product's risks and benefits, the report also said.
药品上市五年后，FDA应该做一个关于这个产品的危险和益处的所有信息的正式的回顾评价，报道也指出。
The FDA requested the report in 2004 after the agency was criticized as being lax in its oversight of Merck & Co Inc.'s arthritis drug Vioxx and other medicines.
FDA需要在2004年做一个报告，当这个机构被指责对默克公司生产的治疗关节炎的万络和其他一些药物的监控疏忽。
The authors said the FDA had taken steps to strengthen its post-approval system but "major obstacles" remained, including "a dysfunctional organizational culture, problems with credibility and public trust and the lack of adequate communication about, and limited public awareness of, drug risks and benefits."
作者说FDA已经加紧步伐巩固上市后认可系统，但是存在主要的障碍，包括组织上功能不完善，公众的信任问题，对药物的危险和收益公众有限的知情程度和缺乏适当的交流。
The report also recommended a six-year term for the FDA commissioner to add stability to the agency. Now, the term is an open-ended appointment by the president. The agency has had a permanent head for just 18 months since President George W. Bush took office 5 years ago.
这个报告也建议FDA用六年的时间来巩固这个机构。现在，这个项目是一个无限制时间的计划安排。自从George W. Bush 总统五年前上任以来，这个机构经历了18个月。 我来试试，大家指正。
The authors said the FDA had taken steps to strengthen its post-approval system but "major obstacles" remained, including "a dysfunctional organizational culture, problems with credibility and public trust and the lack of adequate communication about, and limited public awareness of, drug risks and benefits."
作者认为尽管FDA已经采取步骤来加强上市后认证系统，但其主要问题仍未解决。这些问题包括团体文化混乱，社会信任丧失，对药物使用风险和益处与公众缺乏足够交流导致知情不足。
The report also recommended a six-year term for the FDA commissioner to add stability to the agency. Now, the term is an open-ended appointment by the president. The agency has had a permanent head for just 18 months since President George W. Bush took office 5 years ago.
这份报告还建议给FDA局长六年任期来巩固FDA稳定性。现在，这个任期是由总统无限制任命。而自George W. Bush 上任五年以来，FDA局长最长才任职了18个月。 谢谢ldguan战友
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作者:admin@医学,生命科学 2011-03-09 17:12
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