Regulatory Open Forum

Dear community,

My company submits an IND for a Phase 1. And FDA provides some non-hold comments.
Some of these comments require us to correct and add/update certain information in the previously submitted IB.

My question is:
Do we need to provide an IB amendment ? Or to prepare a new version of the IB ?

Thank you for your help.

Nathalie
New regulatory associate

Hello Nathalie,

In my experience, if the feedback was provided in a formal written format (letter, response, etc.) they typically provide direction for providing that information.  Is your IND still under review or have they issued a decision?  If you are still in the interactive review period an email with the revised document might suffice.  Ultimately, I would recommend an informal (email or call) contact with your lead reviewer to confirm.  If your team agrees to make the changes, I would process it through your QMS to track changes - whether you provide it for review to FDA.

------------------------------
Scott Bishop
Houston TX
United States
------------------------------

Yes, IB amendment for current distribution to the IRB/FDA, Investigators but at the annual update version 1.1.