Hello,
The only IND submissions for which there is a formal response/review time for FDA is for a new IND (30 days), or for FTD/BTD/RMAT/SPA (60 days). It is undefined for all other IND amendments including CMC amendments, NC & C info amendments, etc. In most cases there is no need to follow up to ask if it is ok to proceed. However, for significant CMC amendments, I usually allow for 30 days then call/email the FDA PM if I do not hear anything in this period of time. They won't spontaneously tell you it is ok to proceed but they will get in touch if they have serious concerns or objections, either via phone or via email,
There are no good rules to follow on this, but it never hurts to call/email the PM if you have questions or want to know if FDA does not want the sponsor to implement the change.
Best Regards,
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Charlene Revel
Associate Director, Regulatory Science
Cambridge MA
United States
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Original Message:
Sent: 18-Oct-2021 12:21
From: Anonymous Member
Subject: IND Amendment
This message was posted by a user wishing to remain anonymous
Once an IND Amendment is submitted what is the usual turn around time for the agency. Also, how do the agency communicate (email/ mail) to tell the sponsor if the technical contents are approved or some deficiencies need to be corrected.
Thank you in advance.