Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I have a major protocol amendment to submit to the FDA (dose change request). For this, should I submit to the FDA for review and the central IRB at the same time, or, do I need to obtain the FDA approval of the protocol amendment before submitting to the IRB? I can't seem to locate anything conclusive on this. Thank you!

Please submit the protocol amendment to the FDA and IRB around the same time. FDA does not send approval letters to the Protocol amendments. Or if you wish wait for 30 days from the FDA submission date(since this is a dose change request) and submit it to the IRB. If the dose change is due to safety reason, submit the amendment immediately to FDA/IRB.

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GRSAOnline
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Original Message:
Sent: 07-Sep-2022 15:33
From: Anonymous Member
Subject: Protocol amendment FDA+IRB approval

This message was posted by a user wishing to remain anonymous

Hello,

I have a major protocol amendment to submit to the FDA (dose change request). For this, should I submit to the FDA for review and the central IRB at the same time, or, do I need to obtain the FDA approval of the protocol amendment before submitting to the IRB? I can't seem to locate anything conclusive on this. Thank you!