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For example, in cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S

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I also think that the experts I chatted with are really motivated to try to make changes on the regulation side and the insurance side to get at the root of the problem so that folks aren't pushed online searching for answers