Guidance for Industry and FDA Staff1 FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND

Title:
Guidance for Industry and FDA Staff1 FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND

https://www.gmp-compliance.org/files/guidemgr/Foreign clinical studies.pdf

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry
Content:
Acceptance of Foreign Clinical Studies

Go back