Minor changes or changes that do not raise product-related safety concerns for IND sections that have already been submitted to the original IND i.e., stability data, minor updates may be submitted in the annual report only. It is ok to report minor changes on a regular basis too, but not more than once every 30 days. Please refer to https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-annual-reports and https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-information-amendments. Thank you.
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Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager at CBER - OTP
US Food and Drug Administration
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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Original Message:
Sent: 10-May-2024 16:00
From: Anonymous Member
Subject: IND Annual Report
This message was posted by a user wishing to remain anonymous
Hi-
Our annual reporting period for an IND is quickly approaching and I want to be proactive in finding out information about CMC amendments/changes.
Is it allowed to submit minor CMC changes within the annual report or do the changes have to be submitted during the reporting period and simply list the changes in the Annual Report? I have check the Regs and FDA guidance and could not find a clear answer on how to submit minor CMC changes to an IND. I would appreciate if someone could guide me on where to look or simply share their experience on this topic.
Thank you!