FREQUENTLY Asked Questions
Is the name and address of the research facility a sufficient description for supporting information intended for FDA acceptance of foreign clinical studies not conducted under an IND?
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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.

No, the name and address of the research facility is generally not a sufficient description to meet the requirement in 21 CFR 312.120(b)(2). Because FDA is generally less likely to be familiar with the research facilities in which foreign non-IND studies are conducted, greater detail is usually needed. For example, it would generally be adequate to identify and briefly describe the academic medical center, hospital, physician’s office, clinical research unit or other type of facility at which the research is being conducted. The description should include enough information to enable FDA to determine the adequacy of the facilities to execute the protocol requirements (e.g., whether the site is appropriately staffed and equipped to conduct the proposed research and is able to provide the appropriate emergent or specialized care, if required).

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