"FDA Acceptance of Foreign Clinical Studies Not Conducted Un

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"FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions." This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the requirements of 21 CFR 312.120. It provides recommendations for the submission of information, whether in an IND or application for marketing approval for a drug or biological drug product, to demonstrate that a non-IND foreign clinical study was conducted in accordance with GCP.
The document is now available using the following web link:
http://www.fda.gov/downloads/Regulatory ... 294729.pdf