# FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions:  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/fda-acceptance-of-foreign-clinical-studies-not-conducted-under-an-ind-frequently-asked-questions-guidance-for-industry-and-fda-staff/5708effd-f435-4af2-bdba-f8d7590073d4

> FDA guidance document: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions:  Guidance for Industry and FDA Staff. Issue date: March 01, 2012. Get complete insights and analysis.

---

## Details

- Title: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions:  Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2012-03-01
- Last Changed: 2025-02-03

## Related Documents

- [Considerations When Transferring Clinical Investigation Oversight to Another IRB:  Guidance for IRBs, Clinical Investigators, and Sponsors](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-when-transferring-clinical-investigation-oversight-to-another-irb-guidance-for-irbs-clinical-investigators-and-sponsors/fe8296e5-3ca7-4209-9920-27aa4635ee35)
- [E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers](https://www.globalkeysolutions.net/guidances/guidance-document/e7-studies-in-support-of-special-populations-geriatrics-questions-and-answers/763c730c-788a-48d7-a8b1-a2867830bfc9)
- [IRB Continuing Review After Clinical Investigation Approval:  Guidance for IRBs, Clinical Investigators, and Sponsors](https://www.globalkeysolutions.net/guidances/guidance-document/irb-continuing-review-after-clinical-investigation-approval-guidance-for-irbs-clinical-investigators-and-sponsors/7c18de8c-1544-4b72-a67a-3a861d29c31c)
