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How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

The sponsors can submit information to FDA that was gathered for a foreign clinical study that was not conducted under an IND but only to support clinical investigations in the United States and/or marketing approval (under 21 CFR 312.120). It is highly recommended to clearly state that information about a foreign clinical study and the material that is being submitted is in accordance with 21 CFR 312.120.

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