No. A sponsor may choose, but is not required, to conduct a foreign clinical study under
an IND. When a foreign clinical study is conducted under an IND, all FDA IND
requirements must be met unless waived (see #12 and #13 below). When the foreign
clinical study is not conducted under an IND, the sponsor must ensure that this study
complies with 21 CFR 312.120, “Foreign clinical studies not conducted under an IND,” if
the sponsor intends to submit the study to FDA to support clinical investigations
conducted in the United States and/or marketing approval. An application based solely
on foreign clinical data must meet criteria listed in 21 CFR 314.106.
