FDA Guidance: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND

FDA issued the following guidance, "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions."  The guidance is intended to clarify the requirements if 21 CFR 312.120 and it also provides recommendations for IND's or MAA"s on how to provide evidence of GCP compliance of a non-IND foreign clinical study. 

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf