Michael Varrone回答：

So the FDA has always struggled with trying to increase the review process，and getting products to the market more quickly.

FDA一直在努力尝试加快审评流程，让产品更快地进入市场。

And this administration has come in with a lot of individuals who are questioning current processes and procedures，and coming up with innovative ways.to address the issues with clinical trial design,with review times in particular,and with the ultimate goal of getting safe and effective products out sooner to the public.

本届政府上任后，许多人对现有的流程和程序提出了质疑，并提出创新的方法。来解决临床试验设计方面的问题，尤其是审评时间的问题，最终目标是更快地向公众提供安全有效的产品。

And Dr. Makary, the new commissioner of FDA,is definitely an individual who's looking for new ways,and to implement to increase the speed of the review.

FDA新任局长Makary博士,就是这样一位寻求新方法并实施以提高审评速度的人。

And to do that, he's offered a couple of different approaches.One of them is using artificial intelligence in the review process and in the clinical trial space,and also leading up to the clinical trial space in actual trials in lieu of potential animal studies, I should say.So they're looking at platforms for AI technology.

为此，他提出了几种不同的方法。其中之一是在审评过程和临床试验领域使用人工智能，也包括在临床试验之前的实际试验中，用它来代替潜在的动物研究。所以他们正在研究AI技术平台。

One of the other issues that Dr. Makary wants to address,is the speed of review with these voucher programs.Chris mentioned in his talk a little bit earlier this commissioner's voucher review,where for certain drugs that the FDA deems as a national interest, they would focus the review,create more communication with FDA, more opportunity for communication with FDA,and ability to work those issues out early on in the process,and create more of a rolling review of the application,where the bulk of an application can be submitted early and reviewed early.

Makary博士想要解决的另一个问题是通过审评券计划加快审评速度。Chris在他之前的演讲中也提到了这个局长审评券计划：对于FDA认为具有国家利益的某些药物，他们会集中审评，创造更多与FDA沟通的机会，并在流程早期解决这些问题，同时创建对申请进行滚动审评的机制，使申请的大部分内容可以提前提交并提前审评。

And then at the end, the clinical trial information submitted,and reviewed quickly with a interdisciplinary board of doctors and scientists,who can all review it at once for a quick review and potential approval of the application.Those are just two of the options at this time.

而临床试验信息可以最后提交，并由一个医生和科学家组成的跨学科委员会快速审评，他们可以同时对申请进行审评，以实现快速审评并可能批准申请。这只是目前提出的两种选择。

Christopher Fanelli回答：

Yeah, and I think it's important to highlight,FDA is, I think, publicly, at least in terms of the public statements Dr. Makary and others are making, are very positive on artificial intelligence,and the possibility of artificial intelligence to, as Mike indicated,eliminate potentially the need for animal studies,accelerate some of the early stage human studies,

是的，我认为需要强调的是，FDA至少在公开声明中，例如Dr. Makary和其他人所做的声明，对人工智能持非常积极的态度，认为人工智能有可能，正如Mike所指出的，消除对动物研究的需求,加速一些早期的人体研究，

and then from a review perspective,help speed the agency's review of applications,because these are voluminous,they take anywhere between 10 to 12 months to review,depending on the type of application. Some applications with priority review or accelerated approval may be reviewed more quickly.

然后从审评的角度来看，帮助加快FDA对申请的审评，因为这些申请内容非常庞大，通常需要10到12个月的时间来审评，具体取决于申请的类型。某些具有优先审评或加速批准资格的申请可能会被更快地审评，但AI有潜力加速整个流程。

I will say, from a cautionary perspective,FDA's actual execution or application of FDA's AI application is,the early reviews are extremely limited, right? The data set that was used to train it is apparently quite small, and not really encompassing kind of company data, due to limitations on the ability to kind of integrate third-party data into the AI application,for reasons of confidentiality and otherwise, right?And so it's going to be a little slow, I'd say.

我想说，从谨慎的角度来看，目前FDA实际执行或应用AI应用的情况是，早期审评是非常有限的。用于训练AI的数据集显然非常小，并且并未真正涵盖公司数据，这是由于在将第三方数据整合到AI应用中的能力方面存在限制，比如保密性等问题。所以，我认为进展会比较缓慢。

Certainly, it's not the accelerated AI pathway that we're seeing in China.I think FDA is going to take a more measured, clunkier approach, to adopting AI tools to review applications, for example.

当然，这不像我们在中国看到的加速AI路径。我认为FDA在采用AI工具审评申请等方面，将采取一种更谨慎、更凝重的方法。

So it's very exciting,but certainly FDA will not be moving at the pace that I think the Chinese regulators are moving, in terms of their adoption of AI.

所以这非常令人兴奋，但FDA的行动速度肯定不会像我认为的中国监管机构在采用AI方面那么快。