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

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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.

About the Author
Proxima CRO Team
Aryan Abedi
Quality Assurance Intern

Aryan received his B.S. in Biomedical Engineering from Texas A&M University. He has experience in Design and Development, Quality Control, and Quality Assurance and is particularly interested in the use of biomaterials and production of cost-effective medical devices to improve quality of life for patients from various socioeconomics background.  

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