Under 21 CFR 312.120, the sponsor can submit information to FDA from a foreign
clinical study that was not conducted under an IND to support clinical investigations in
the United States and/or marketing approval. When submitting information about a
foreign clinical study, it is helpful to clearly identify in the cover letter that the material is
being submitted in accordance with 21 CFR 312.120. The submission requirements for
supporting documentation can be found at 21 CFR 312.120(b).