What information should the sponsor or applicant submit to FDA to show that the study is adequate and well controlled under 21 CFR 314.126?

As an example, integrated, full CSRs in accordance with ICH E3 generally provide appropriate detail to show that the study is adequate and well-controlled as described in 21 CFR 314.126. Note: the sponsor or applicant should also explain how the foreign data are applicable to the U.S. population and U.S. medical practice.