药品监督管理

2003-2004年国家食品药品监督管理信息化发展概况

Overview on Development of State Food and Drug Supervision Informatization in 2003-2004

完善药品监督管理适应《行政诉讼法》的实施

Perfecting Drug Supervision in Accordance with Administrative Procedure Law

但是美国食品药品监督管理局尚未批准安维汀用于眼部,使用安维汀代替诺适得可能会带来额外的轻微安全风险。

But the Food and Drug Administration has not approved Avastin for use in the eye , and using it rather than the alternative , Lucentis , might carry an additional , although slight , safety risk .

这两种药物有望在今年夏天赢得美国食品和药品监督管理局（FoodandDrugAdministration）的批准。

Both drugs could win approval from the Food and Drug Administration by this summer .

中国食品药品监督管理局（thechinesefoodanddrugadministration）表示，传统中药占总体药品市场的36%。

The Chinese food and drug administration says it represents 36 per cent of the total medicines market .

中国国家食品药品监督管理总局（ChinaFoodandDrugAdministration）在临床试验监管方面行动缓慢，往往被认为是另一个障碍。

Slow-paced regulation of clinical trials by the China Food and Drug Administration is often cited as another obstacle .

这种新的DNA疫苗和治疗流感的方法尚未获得美国食品药品监督管理局的批准。

The new DNA vaccine and new administering device for influenza is not yet FDA approved .

美国食品药品监督管理局（FDA）是在曝出危险药品丑闻后成立的。

the Food and Drug Administration appeared after scandals over dangerous medicines .

问题1。美国食品药品监督管理局（FDA）今天宣布批准了什么药物？

Q1.What is the U.S.Food and Drug Administration ( FDA ) announcing today ?

美国食品和药品监督管理局（FoodandDrugAdministration）和美国国家环境保护局（EnvironmentalProtectionAgency）的现行指南警告：孕妇和哺乳期妇女应将金枪鱼的摄入量限制在每周6盎司（约合170克）。

Current guidelines from the Food and Drug Administration and the Environmental Protection Agency warn pregnant and nursing women to limit tuna consumption to six ounces per week .

2008年，美国食品药品监督管理局（FDA）裁定克隆牛的做法安全。

In 2008 the US Food and Drug Administration ruled that the practice was safe ;

两款设备都得到了美国食品与药品监督管理局（FDA）的批准，但它们使用起来有所不同，配套应用也不一样。

Both are FDA approved , though they operate a bit differently , and their companion apps are different .

所有产品均通过国家食品药品监督管理局GMP认证。

All her products are GMP certified by the State Food and Drug Administration ( SFDA ) .

国会正在考虑一项禁止美国食品药品监督管理局（FDA）批准人类胚胎相关临床应用的法案。

a proposal being considered in Congress would ban the Food and Drug Administration from approving clinical applications in human embryos .

ADR监测工作是药品监督管理的重要组成部分，是集专业技术、组织管理于一体的复杂的综合性工作，也是一项长期的任务。

ADR monitoring is an important part of drug administration , it is all-around task that consist of speciality technology and organization administration .

国家药品监督管理局（SDA）负责药品的行政保护；

The State Drug Administration (" SDA ") was responsible for administrative protection of pharmaceuticals ;

就像美国食品药品监督管理局（FDA）前局长戴维·克斯勒（DavidKessler）喜欢说的那样，这里简直是在举办粮食嘉年华。

It is , as the former Food and Drug Administration commissioner David Kessler likes to call it , a food carnival .

为了开发安全有效的细胞病毒疫苗，美国食品与药品监督管理局（FDA）已经向制造商颁布了新的指导规范。

The U.S.Food and Drug Administration ( FDA ) has issued new guidance to aid manufacturers in developing safe and effective cell-based viral vaccines .

他建议将美国食品药品监督管理局（FDA）作为榜样。该机构利用科学家和独立机构来决定哪些药品可允许上市。

He suggests as a model the US Food and Drug Administration , which involves scientists and independent bodies deciding what drugs are permissible .

美国食品药品监督管理局（FDA）最近首次设定鱼肉最小摄入量指标，强调了食用更多低汞含量鱼的益处。

The US Food and Drug Administration recently set its first minimum fish consumption target , emphasising the benefits of eating more low-mercury fish .

美国食品和药品监督管理局（FoodandDrugAdministration）现已批准了至少三种鱼油产品——Vascepa、Lovaza（ω-3脂肪酸乙酯胶囊）和一种仿制药——作为治疗甘油三酯过高（心脏病的一个风险因素）的处方药。

And the Food and Drug Administration has approved at least three prescription types of fish oil - Vascepa , Lovaza and a generic form - for the treatment of very high triglycerides , a risk factor for heart disease .

2005年应国家药品监督管理局邀请，参与了药用辅料GMP定稿工作会议和药用辅料管理办法的讨论会；

In2005 the State Drug Administration should be invited to participate in the conference final GMP pharmaceutical excipients and medicinal material management practices seminars ;

该药物名叫氟班色林（flibanserin），去年获得了美国食品和药品监督管理局（FoodandDrugAdministration，F.D.A.）的批准，从而成为了第一种用于治疗女性性欲低下的药物。

Last year the Food and Drug Administration approved the drug , flibanserin , making it the first drug available to treat low sexual desire in women .

它还企图误导美国食品药品监督管理局（fda），不让后者掌握到底有多少青少年在研究试验中因服用帕罗西汀而做出伤害自身的行为或企图自杀。

It also attempted to mislead the food and Drug Administration about how many adolescents had injured or attempted to kill themselves after taking Paxil in research trials .

从加拿大进口的13C鄄尿素试剂已获得国家食品药品监督管理局许可并应用于临床。

13C-labelled urea imported from Canada has been permitted by the State Food and Drug Administration to be used in 13C-UBT in clinic .

特鲁瓦达是目前唯一被美国食品和药品监督管理局（FoodandDrugAdministration，F.D.A.）批准用于PrEP的抗逆转录病毒药物，但它的制造商吉利德科学公司（GileadSciences）却未曾给它的这一用途做过广告。

Truvada is currently the only antiretroviral drug approved by the Food and Drug Administration for PrEP , but its maker , Gilead Sciences , does not advertise it for that purpose .

美国食品药品监督管理局（U.S.FoodandDrugAdministration）曾发现，很多中国药品供应商对血液稀释剂“肝素”提供过受污染的药物成分，此事导致美国2008年80人死亡，数百人产生了过敏反应。

The U.S. Food and Drug Administration found that many Chinese drug suppliers provided contaminated ingredients for the blood thinner heparin , which in 2008 led to the deaths of 80 people and the allergic reactions of hundreds of others in the U.S.

临床试验是新药的上市之前非常重要的一步，这是FDA（美国食品药品监督管理局）批准的前提，也是试验药物到底是否安全的标准。

Clinical trials are the most important step in getting a drug approved by the FDA , and without them , no one would know if their medicines were safe .

美国食品药品监督管理局（fda）上月公布了一封信函，批评百特在中国的一家分包商未能解决所供药品的质量问题。

The comments come after the US Food & Drug Administration released a letter last month criticising a Chinese sub-contractor to Baxter for failing to remedy quality problems in supplies .

福利经理杰恩·加利亚诺（JayneGagliano）说自己经常需要向外州的保险公司解释使用特鲁瓦达预防H.I.V.感染实际上已经经过了美国食品和药品监督管理局（FoodandDrugAdministration，F.D.A.）的审批。

Jayne Gagliano , the benefits manager , said she regularly had to explain to out-of-state insurers that using Truvada to prevent infection was , in fact , F.D.A. - approved .