FREQUENTLY Asked Questions
How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?
View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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.

Related FAQs:
More Questions? We're here to help!