Christopher Fanelli回答:
which is FDA's current policy objective, at least as they state it, and I think it's open to interpretation, is that, you know, overseas companies have not historically been held to the same standard as domestic companies, just by virtue of the fact that FDA typically isn't present all the time at those overseas companies, or in those countries.
即FDA当前的政策目标,至少从他们声明来看,当然我认为这可以解读为海外公司过去没有被要求遵循与国内公司相同的标准,这是因为FDA通常不会一直出现在那些海外公司,或者说那些国家的现场。
And so, you know, part I think what we're seeing at FDA now is a reaction to say, no, we want to level the playing field between US and non-US companies, and some of the actions that we're seeing,are an intent towards saying the playing field needs to be leveled.
所以,我认为我们现在在FDA看到的一部分反应是,不,我们希望在美国公司和非美国公司之间创造一个公平的竞争环境,而我们看到的一些行动,就是为了表明竞争环境需要公平。
And so as a result, we're going to increase scrutiny of overseas companies, and hold them to the same standard that we've been holding US companies. And so I wouldn't say that it's, you know, they're trying to hold them to a higher standard. It's more the idea being that the current policy is to say the standard should be the same.
因此,我们将加强对海外公司的严格审查,并要求他们遵循我们一直以来对美国公司要求的相同标准。所以我不会说他们试图对海外公司提出更高的标准。更准确地说,当前政策是主张标准应保持一致。
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