美国食品药品监督管理局

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 .

选项之一是进行简单的呼吸检测，即将开始对该病药物进行人体试验的伦敦生物科技公司TizPharma的首席医疗官伊兰？亚龙（IlanYaron）说，“美国食品药品监督管理局目前还不认可这些检测方法，但将来会认可的。”

One option is a simple breath test , according to Dr Ilan Yaron , chief medical officer of Tiz Pharma , a London-based biotech group that is about to start testing its Nash drug in humans . " The FDA does not recognise these tests yet , but it will in time , " he says .

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 .

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 ?

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 ;

通过鼓励患者将药品用于美国食品药品监督管理局（USFoodandDrugAdministration）批准范围之外的用途，葛兰素史克取得了可观的短期销售业绩，但也为监管机构的一系列整治行动埋下了种子。

By promoting drugs beyond the uses approved by the US Food and Drug Administration , GSK generated substantial short-term sales but lay the foundations for a series of regulatory actions .

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 .

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 .

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 .

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 .

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 .

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”。只不过门票价格太高。

It is , as the former Food and Drug Administration commissioner David Kessler likes to call it , " a food carnival . " It 's just that there 's a steep ticket price .

里士满，弗吉尼亚州（美联社）。美国食品药品监督管理局（FDA）声称必须重新对超过四年的引进或改良的烟草产品进行评估，以利于企业的销售。

RICHMOND , Va. ( AP ) & The Food and Drug Administration says it must review tobacco products that were introduced or changed over the last four years in order for companies to keep selling them .

在与美国食品药品监督管理局（FDA）讨论后，Intercept表示，试验必须显示该药能够治疗非酒精性脂肪性肝炎，或者改善“肝纤维化”（肝脏瘢痕的医学名词）症状。

Following discussions with the US Food and Drug Administration , Intercept said the trial must now show that the drug can either resolve Nash or improve " fibrosis " - the medical term for liver scarring .

他们认为，销售商如果要打通国际政治、商标限制、美国食品药品监督管理局（F.D.A.）法规等错综复杂的体制网络，还需要多年的时间。

It will take years , they say , for sellers to clear the byzantine network of international politics , trademark restrictions and F.D.A. regulations .

如果美国食品药品监督管理局（FDA）接受其顾问委员会的建议（往往会接受），将标志着该机构首次批准此类疗法，并预示着一个新药物时代的到来，即通过植入缺失或变异基因的运转正常的副本来治疗疾病。

If the US Food and Drug Administration accepts the recommendation of its advisory committee , as it tends to , it would mark the agency 's first approval of such a treatment and herald a new era of medicine where diseases are tackled by inserting functioning copies of genes that are missing or mutated .

目前，获得美国食品药品监督管理局批准的只有两种药物。

Currently , only two treatments are approved by the U.S. Food & Drug Administration .

美国食品药品监督管理局还批准了莫德纳和强生公司的疫苗用于紧急使用。

The FDA has also approved vaccines from Moderna and Johnson & Johnson for emergency use .

美国食品药品监督管理局的最新决定基于对4万名16岁及以上志愿者的研究。

The FDA based its latest decision on a study of 40000 volunteers 16 years and older .

美国食品药品监督管理局表示，该产品已知和潜在的益处大于其已知和潜在的风险。

The FDA says the known and potential benefits of the product outweigh the known and potential risks of the product .

美国食品药品监督管理局表示，该疫苗在紧急情况下仍可用于12至15岁的年轻人。

The FDA said the vaccine continues to be available under emergency use for young people between the ages of 12 and 15 .

但是这些已经上市销售的或者已经在美国食品药品监督管理局最后审查阶段的减肥药总是因为副作用而被迫退出市场。

But those that have reached the market or gotten to the final stage of FDA vetting have repeatedly been sidelined by side effects .

他对美联社工费，“我认为很多企业一直在等待”美国食品药品监督管理局的全面批准。

He told The Associated Press , " I think a lot of businesses have been waiting for " the full approval from the FDA .

本文介绍了美国食品药品监督管理局关于抗菌药物临床试验非劣效设计的考虑。

This article is to introduce FDA 's ( Food and Drug Administration , FDA ) considerations of non-inferiority design used in anti-bacterial drug clinical trial .

在其他地方还有6种抗艾滋病病毒药物处于试验的后期阶段，有两种正等待美国食品药品监督管理局的批准。

Elsewhere , six new anti-HIV drugs are in advanced stages of testing , with two waiting for approval by the United States Food and Drug Administration .

这款疫苗由辉瑞及其德国合作伙伴德国生物新技术公司联合生产，是去年12月获得美国食品药品监督管理局紧急使用授权的首个疫苗。

The vaccine , made by Pfizer and its German partner BioNTech , was the first shot to be approved for emergency use by the FDA last December .