Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

This message was posted by a user wishing to remain anonymous

Please don't be too concerned, just submit the waiver now for all the Ex-US sites explaining the oversight! The key point is submitting the waiver now would document your due diligence which is more critical. The FDA may not act on this immediately and may take long time to send you the letter so don't delay starting of your trial, if this a registrational trial.

Original Message:
Sent: 04-Feb-2024 21:56
From: Anonymous Member
Subject: Ex-US sites activated without 1572 Waiver

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

Upon reviewing our records, I discovered that several sites were activated without the prior submission of waiver requests to the FDA. This oversight was identified for both already activated sites and a few that are pending activation.

Given this scenario, I am contemplating whether to:

1. Submit a single waiver request covering all sites, including both activated and not yet activated, or

2. Prioritize submitting waiver requests for the already activated sites before addressing the not yet activated sites.

I am unsure of the best course of action, particularly because the initial waiver requests were not submitted in accordance with the standard procedure before the activation of these sites. My goal is to rectify this oversight and ensure compliance with FDA requirements.

Could you provide guidance on how best to approach this situation in the cover letter to the FDA? Additionally, if anyone has insights into the potential implications of late waiver submissions for activated sites or recommendations on how to frame this in communication with the FDA to effectively close this loop, your advice would be greatly appreciated.

Thank you for your assistance and expertise.

This has been a popular topic on this forum in the past 1-2 years. Search the history around January 2023 and you'll find many posts Submitting a waiver is not the only option. FDA issued We handle ex-US sites as non-IND sites.  FDA also updated their Q&A guidance in March 2021 on this topic - FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND
Frequently Asked Questions.

------------------------------
Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
------------------------------

Original Message:
Sent: 05-Feb-2024 09:16
From: Anonymous Member
Subject: Ex-US sites activated without 1572 Waiver

This message was posted by a user wishing to remain anonymous

Please don't be too concerned, just submit the waiver now for all the Ex-US sites explaining the oversight! The key point is submitting the waiver now would document your due diligence which is more critical. The FDA may not act on this immediately and may take long time to send you the letter so don't delay starting of your trial, if this a registrational trial.

Original Message:
Sent: 04-Feb-2024 21:56
From: Anonymous Member
Subject: Ex-US sites activated without 1572 Waiver

This message was posted by a user wishing to remain anonymous

Dear Forum Members,

Upon reviewing our records, I discovered that several sites were activated without the prior submission of waiver requests to the FDA. This oversight was identified for both already activated sites and a few that are pending activation.

Given this scenario, I am contemplating whether to:

1. Submit a single waiver request covering all sites, including both activated and not yet activated, or

2. Prioritize submitting waiver requests for the already activated sites before addressing the not yet activated sites.

I am unsure of the best course of action, particularly because the initial waiver requests were not submitted in accordance with the standard procedure before the activation of these sites. My goal is to rectify this oversight and ensure compliance with FDA requirements.

Could you provide guidance on how best to approach this situation in the cover letter to the FDA? Additionally, if anyone has insights into the potential implications of late waiver submissions for activated sites or recommendations on how to frame this in communication with the FDA to effectively close this loop, your advice would be greatly appreciated.

Thank you for your assistance and expertise.