makareyou sure什么意思后加什么

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终于懂得整合第三方 app 的资料啦。现在 Google Now 暂时会显示来自 40 个第三方 app 的「Now 卡」,当中较知名的包括 eBay、The Guardian、The Economist、The Economic Times、Pandora 和 Airbnb 等,它们都会根据自身的功能和用户所在地而推出相关的 Now 卡,例如 Pandora 会在通勤时间提供音乐建议,而 The Guardian 则当然会提供新闻卡,至于像 Lyft 这类叫车 app 则会在用户回程到本国机场时,询问用户会不会想叫车回家等。只要大家点按这些卡,就会启动有关的 app 了。最后,担心个人资料外流的你也可以放心,根据华尔街日报指出,Google Now 的资料将不会跟这些已整合的第三方 app 分享的。
在半个月前 Google Glass 正式,以非实验产品的身份交由 Nest CEO 负责发展,现在轮到
了。这个 3D 感应器装置计划比 Google Glass 更迟出现,实验时间更短,它的手机版本在 2014 年 2 月尾才推出,换言之它的实验时间不足一年呢,发展颇快的。现在它将从原来的 ATAP 部门移至一个 Google 内的「新居」,不过 ATAP 并没有透露 Project Tango 未来的走向将是如何。Project Tango 现时已有手机和平板版本,将来也不排除 3D 感应器会出现在其他类别的产品上吧。
在去年五月时 Motorola 发布了
这款只要价 US$120,但仍有不少卖点的廉价手机,而传闻上面这张由 Android Police 取得的图片就是它的第二代了。据图片显示,这部疑似第二代 Moto E 补上了一个对某些人来说很重要的规格,就是前置相机了。就它的背面而言,图中的 Moto E 新增了一个第二麦克风和 (2015)及
均有的环形相机补光灯。
虽然它同时失去了前置喇叭的设计,但如果上述资讯无误的话,那这款 Moto E 可说是终于追上时代的步伐,只希望在补上现代必要规格的同时价格不要大升就好了。不知道它会不会在 MWC 上正式公布呢?
任天堂今天推出一个名为「Creators Program」的计划,以确保 YouTuber 在分享其游戏片段时能有所分成。这计划是因为公司在 2013 年对于「Let's Play」所上载的游戏视频提出下架或加入广告的要求,原因是他们声称自己对有关片段有版权保护。在去年的玛利奥赛车 8 中,公司亦重覆以上的声明,但同时宣布会有的计划。在酝酿了八个月后终于出现了这 Creators Program。
本来 已在 12 月 9 号时,以集资金额超出原有目标 480% 的姿态暂告一段落,想不到日前又再次登上 Indiegogo 集资呢。这次它新增了 64GB 内置储存量的版本,要价 US$249(约 1,490 元人民币),另外还带来一些硬体改善,包括电池量由 4,300mAh 升至 4,450mAh、屏幕玻璃变成全贴合式、加入陀螺芯片和指南针芯片,可是本来配备的距离感应器则被去掉了。此外,在去年 12 月 11 号已投资了 32GB 版本的人可以加 US$25 换成 64GB 版本。
另外,大家要知道的就是原来基于 Microsoft 授权的限制,只要插入 Jolla 平板内的 microSDXC 卡容量是大于 32GB 都会被平板格式化,里面的东西不能被 Windows 电脑和其他支持 microSDXC 的装置读取。虽然 Jolla 也表示他们明白这个安排的不便之处,但仍认为这符合他们 Jolla 社区用户的期望。
又到了各大公司发出去年第四季度财报的时候了,Google 在其,其 2014 第四季度的总收入为 181 亿美元。可是这数字并不如大部份华尔街分析师的预计,这是到底甚么一回事了?
之前有报导过著名的第三方键盘应用程序 SwiftKey 推出支持中文输入法的 Beta 版本,在经过一段时间的测试以后终于要除下 Beta 的标签。而且他们为了配合农历新年,还推出了一个充满节日气息的新主题供使用者下载呢。
一如之前的 SwiftKey Chinese Beta,在正式版本也会加入拼音、注音、速成和仓颉输入法。另外新版本键盘上加入了 SwiftKey Heatmap,用以追踪使用者的打字习惯,并提升准确度;键盘的展开和收纳速度亦有上升,让使用时更爽快。包含以上更新的 SwiftKey 5.2 已经在
上架,有兴趣的朋友可以去下载试试啊。
多年来东芝以「Cloud Portal」和
为重建其电视部门的主轴,但这俩都没有在北美洲以外上市。相比其他已经放弃()、缩减规模()或重组()的日本同业,东芝则选择了把名字以特许经营方式交由台湾公司仁宝使用。最快会在三月推出第一台在这形式下生产的电视,所以日后的东芝 电视可能会多了一股台湾的味道吧。继 2013 年在电视部门后,东芝的这一步显得让人费解。无论如何,公司会继续朝向在稳定盈利下继续「开发新科技和服务」的计划营运。
在商业用电邮平台上,微软和 Google 占到了市场的大多数。可是一直动作多多的亚马逊却想要挑战前者的 Exchange 服务,推出自家的商业用电邮平台。
Amazon Web Services(亚马逊的商用服务器部门)的策略并不会要求使用者完全把 Exchange 换掉,而是提供安全的后台。也就是使用者可以继续使用 的电邮和日历功能,但数据则会通过亚马逊的云端处理。收费方面预计是每位用户每月 4 美元,并在夏季推出服务。
[图片来源:Getty]
今天早些时候,苹果正式上线了最新的
12.1 版本。这版应用最大的变化,在于新增了通知中心 Widget,让使用者可以直接在其中完成播放、暂停、跳过等操作。除此之外,当用户收听 iTunes Radio 时还可直接购买相应的音乐。不过要提醒大家的是,这个新版本必须要先更新到
才可使用。所以说,快打开 App Store 升级吧。9BUnit2知识点(教育部审定2013版教材)_百度文库
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Ranbaxy因违规被FDA罚款5亿美元
【 日期: | 浏览次数:2089
&&&&南京美新诺医药科技有限公司非常乐意与大家分享最近发生在仿制药界的一个重大事件
&&& 以下是这篇报导的翻译稿(the original article in English is also attached or log-in )
&&&Ranbaxy印度一家可能也是发展中国家最大的仿制药公司存在无数严重违规行为受到指控
&&& 日8:12am发表于:
&&& 上周,Ranbaxy Laboratories同意向美国支付5亿美元的罚金,以解决因其严重和广泛的违法违规行为而在美国引起的刑事和民事诉讼。联邦调查员称这是对仿制药企业最严厉的一次处罚。近十年来,Ranbaxy长期延续利润增长方案,一直保持者低成本仿制药供应的领先地位。Ranbaxy要求科学家们操控报告,强迫其员工非法携带品牌药物的原料到印度,并且由高级管理人员发布假的声明。FDA收到Dinesh Thakur(44岁,曾就职于美国的Bristol-Myers Squibb,在去印度的Ranbaxy工作后决定揭发Ranbaxy的内幕)报告之后,经过调查决定在美国禁止销售30种Ranbaxy生产的药物,并与生产商达成了核准令。Dinesh Thakur七年前返回美国,现在将会因为帮助调查而得到4800万美元的律师费。我们与他讨论了诉讼案中谈到的欺骗事件和从该事件中吸取到的教训,以下是经过编辑的版本。
Pharmalot:据我所知,之前您的儿子有过耳部感染,您给他服用了Ranbaxy的药物,但是一点效果都没有,我猜想这应该是个前兆,事实具体是怎样的呢?
Thakur:那个年龄的孩子的耳部感染,通常都会使用阿莫西林来进行治疗,所以我给他服用儿科剂量的阿莫西林,但是一点效果也没有。这就是问题的所在,我们一直相信这药,一点都没有怀疑过,除非事实摆在那里才能让你质疑它。所以我重新去医生那儿换了GlaxoSmithKline 销售的由Augmentin制造的阿莫西林,这才让我儿子好了起来。
Pharmalot:当您在调查各种欺骗行为时,您看到了很多困惑的事情,这些都已经列在您的控告上书了,其中最让您担忧的是什么呢?
Thakur:我能说的一件事情就是,为任何制药公司工作就得让其制造的并给病人服用的药物有好的前景。而我看到的却是对最基本的信任的完全背离。我看到了许多与记录不符的情况。但这一切的基本前提就是你可以信任这个药物,如果你不能信任的话,那就有大问题了。这就是事件的概况,我没法说其中哪件事情比其他的更糟糕。当你思考我所见到的所有问题的时候,你会发现其实每件都是极其严重的。
Pharmalot:据我所知你已经将所有情况(包括你的担忧)呈报给了FDA,但为什么没有递交给印度官方机构呢?
Thakur:是的,我没有递交给印度的官方机构。我接受的是美国教育,并曾在美国制药企业工作,我了解FDA并熟知它的法规和执行能力。我只想确保所有服用这些药物的病人不要受到伤害。而且在我看来,FDA有经济实力做这件事情。
Pharmalot:在FDA开始禁止或颁布法令前,那些服用过Ranbaxy药物的患者怎么样了呢?他们有没有真正从这个事件获益?
Thakur: 如果你回顾这一系列事件,到上周一为止,FDA已经实施了完整的法令,已经完全禁止了这30种药物进口到美国。很明显,这对美国患者是有益的,并且是一个积极的结果。你可以看一看这个已经通过的法令,如果这个公司想再卖药物到美国的话,他就要达到许多严格的要求。因此,我确信只要他们能够兑现自己的承诺,那么所有在美国销售的药物的质量都会提高。如果你还记得的话,FDA的发言人曾说过,他们没有发现这些药物的样品有任何问题。
Pharmalot:据我所知,您从Ranbaxy辞职并揭露造假事件后就为自己和家人请了私人保镖。您真的受到过威胁吗?
Thakur: 他正准备作出回应时,他的律师Andrew Beato打断他并指出:刚过去的一段时间,在印度发生过20起对举报者的严重报复事件,他们曾经接到过死亡威胁,因为很多人对站出来揭发公司的违法行为有着不同的意见。
Pharmalot: Ranbaxy没有任何执行官或管理层的个人因此而被处罚,你对此感到惊讶或失望吗?
Thakur:对此我不能做评论,我所做的就是,将我有的信息都递交给FDA的调查员们,他们自己从这些信息中获得结论。我没有直接针对任何个人的证据。我做了我该做的,下面就是FDA的工作了。
Pharmalot: 你是否认为某个或者更多的个人应该单独出来承担责任呢?
Thakur:我不知道政府为什么做了这些事情。我不了解他们的决策过程,所以我不好说。我在Ranbaxy看到的东西非常的系统和普遍,这超出了个人的能力范围,所以我真的不能说某个人应该出来承担责任。这应该是政府的事情。
Pharmalot:你认为行业中的其他企业应该从这一事件中吸取什么教训呢?
Thakur:当你在谈论行业的时候,事情就发生了变化。从我2003年开始去Ranbaxy工作到现在为止,如果你去看一下去年通过的食品,药品,安全与创新法案的话, FDA已经在海外具有很多资源并设立了检查机构,这些已经能够对全球供应链进行监督了。对某件事情进行这样大的行动是很难的,但据我所见,FDA已经做了它能做的事情了。
&&&&必须采用一个有效的程序对全球生产的药物的质量进行验证。许多关注都集中在是否违反GMP上。司法部门在今年年初的时候出来声明说这将会成为他们必须进入的一个工作领域。FDA的全球化倡议有望解决这个问题。国会已经将(国外的)美国的制造工厂资料都提供给FDA了。我想我们需要强化规定,这样才能引起这些公司的注意。
&&&&这件案子的挑战就是他们知道他们能够脱身事外。(在Ranbaxy)他们已经提前知道FDA检察官来Paonta Sahbi的时间。如果我们能够对他们严格监管,在他们做那些没有意义的事之前就让他们知道他们面临的是多么严格的标准,那这些事件有可能就不会发生。但是我很高兴这件事情有了结局,并且希望人们能用上更安全的药。
Pharmalot:您呢?您下一步打算做什么?做顾问还是制药者呢?如果你拿到此次事件支付的资金以后,你是否还要工作?
Thakur:我在过去的几年已经学到了很多东西,同时有一个机会可以让我将所学的东西与大家分享。我愿意将之前8年的经验进行总结,并希望能与那些需要从中国和印度进口原料的公司合作,以确保我们得到的就是我们所想要的质量。
&&&&现在我还没有真的定下来。或许我期盼的工作就是做一个顾问。这与金钱无关。你想想,我与FDA在一起工作过两年,并不是因为最终结果有金钱的原因。钱不是我的动力。如果金钱是动力的话,我会走另外的途径来解决这件事情。如果我认为我所学到的东西能过帮助提高药品的质量,我就认为这是应该做的事情。
Pharmalot:您不打算写一本书吗?
Thakur:我还没有想那么远,但是我确实刚刚开了个小博客。
Ranbaxy Whistleblower: So Many Infractions And Each Was EgregiousPosted Tue, 05/21/2013 - 8:12am by &Last week, Ranbaxy Laboratories agreed to pay $500 million to settle criminal and civil charges in the US for a serious and widespread manufacturing ruse. The feds called this the largest such penalty ever paid by a generic drugmaker for such violations. For nearly a decade, Ranbaxy perpetuated a scheme to boost profits and maintain its edge as a leading purveyor of low-cost generics. Scientists were ordered t other employees were forced to illegally carry supplies of brand-name drugs to India and duplicitous statements were issued by high-ranking executives. The FDA, which later banned 30 Ranbaxy drugs from the US and reached a consent decree with the drugmaker, was alerted to the fraud by Dinesh Thakur, 44, who had worked for Bristol-Myers Squibb in the US and became a whistleblower after moving to India to work for Ranbaxy. He returned to the US seven years ago and will now collect $48 million, less attorney fees, for his role in helping the feds. We chatted with him about the fraud that he detailed in his lawsuit and the lessons learned from this episode. This is an edited version…
Pharmalot: So I read that early on, your son had an ear infection and you gave him a Ranbaxy drug, but it was ineffective. It was a foreshadowing, I guess, but what exactly happened?
Thakur: Children at that age develop ear infections and most often you prescribe amoxicillin and I got a pediatric dose, but nothing happened. That was the troublesome part. You trust the medication. You don’t question it, unless something stands out that makes you question it… So I (went back to the doctor) and the drug was switched for Augmentin, which is sold by GlaxoSmithKline and that made him better.
Pharmalot: As you looked into the various fraudulent activities, you saw a lot of disturbing things, which were outlined in the complaint (), but which of these worried you the most?
Thakur: The one thing that I can say is that working for any pharmaceutical company is that there are expectations for the drugs that are made and that the patients take. What I saw was a basic violation of the trust. There were a number of different things I saw and documented. But it all goes to the basic premise that you trust the medicine and if you can’t, there’s a big issue. But it was a combination of all of these things. I can’t single out one and say this was worse than another. When you think about all the things I saw and, it is in the complaint, each one by itself is an egregious thing ().
Pharmalot: From what I gather you went to the FDA (with your concerns), but not to the authorities in India. Why was that?
Thakur: No, I did not go to authorities there. I was educated in the US and worked in a US pharmaceutical company and I knew the FDA had the most understanding and knowledge of regulations and enforcement capability. And I just wanted to make sure that patients who were taking the drugs were not being harmed. And in my opinion, the FDA had the wherewithal to do that.
Pharmalot: What about the patients who took Ranbaxy drugs before the FDA instituted the ban or the consent decree was issued? They’re not really benefiting from this episode, are they?
Thakur: If you look back at the sequence of events that led to last Monday, with the Application Integrity Policy (), the FDA essentially eliminated 30 drugs from the supply coming into the US. Clearly, this was a benefit to patients in the country and was a positive consequence. And likewise, if you look at the consent decree, it has some onerous requirements of the company if it wants to sell drugs in this country again. As a consequence, I’m sure any drug sold in this country will be of a higher quality, assuming they follow through on their commitments. And if you remember, the FDA spokesman said they did not find any issue with the samples of those drugs.
Pharmalot: From what I’ve read, you hired private security for yourself and your family at one point after resigning from Ranbaxy and disclosing the fraud. Were you actually threatened, though?
Thakur: (He starts to respond, but his attorney, Andrew Beato, interjects by noting there “were 20 acts of serious reprisals against whistleblowers in India” in the recent past and “they have had deaths, because the idea of standing up to corporate malfeasance” is viewed differently.
Pharmalot: There were no individual Ranbaxy executives or managers who were singled out for penalties. Does that surprise or disappoint you?
Thakur: I can’t comment. What I did, whatever information I had, I gave to FDA investigators and they took it upon themselves to bring it to a conclusion. I don’t have any insight into the evidence that was used to bring something against an individual. I did what I had to do and it was up to FDA to work with that.
Pharmalot: Do you think one or more individuals should have been singled out?
Thakur: I don’t know why the government did what it did. I don’t have any insight into their decision making process, so it’s difficult for me to say that. What I saw here was so systemic and so pervasive that it goes beyond one individual so I really cannot comment on any whether one person or individual ought to be held accountable. That’s something the government ought to do with the evidence that they have.
Pharmalot: What lessons do you think others in industry ought to take away from this episode?
Thakur: When you talk about industry, things have changed. From the time I went to work for Ranbaxy in 2003 and now, if you look at the Food, Drug, Safety & Innovation Act passed last year, the FDA has more resources and inspection offices outside the country. And so it is able to respond to the global supply chain… It’s hard to react to something this large, but from what I can see, the FDA is doing what it can.With the big sourcing from global locations, there has to be a process to verify the quality. There is a lot of focus on Cgmp violations.. The Justice Department came out earlier this year and said it will be an area of enforcement for them. The FDA global initiative is on track to address this problem. And Congress gave FDA resources to bring (overseas) manufacturing facilities on par with what exists in the US. I think we need to have strengthened rules so that companies know they are going to get caught…The challenge in this particular case was because they knew they could get away with it. (At Ranbaxy), they knew ahead of time the FDA inspector was coming to Paonta Sahbi. If you take that comfort away, they will know they will be subject to the same standards before they do that kind of nonsense. But I’m very happy this has come out and … hopefully we’lll have safer medicines for people.
Pharmalot: And what about you? What will you do next? Work as a consultant or for a drugmaker? Will you work at all, given the settlement?
Thakur: I’ve learned a lot over the last years and clearly there’s an opportunity for me to share what lessons I’ve learned. I’d like to use the experience of the last eight years to get my point of view out there and hopefully work with companies that buy source ingredients from China and India and mak sure the quality we want is what we get.At the moment, I haven’t really narrowed it down. Probably working as a consultant would be something I’d look forward to… This wasn’t about money. When you think about it, for two years, I worked with FDA, but not because there was a pot of gold at the end of the rainbow. That was not a driver. If money was a driver, I would have taken a different route. If I believe the lessons I’ve learned can help the quality of the drug supply, I think it’s something I should be doing…
Pharmalot: You’re not going to write a book?
Thakur: I haven’t gotten that far. But I did just start a small blog.
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