Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
I work with a company whose historical approach to writing M2.5 for a new IND is to cross-refer the FDA to already-open INDs for the same drug.  For example, instead of providing summary text on the biopharmaceutics or clin pharm sections, the medical writers are cross-referring the FDA to previously-submitted informatoin by stating: "Please refer to the clin pharm section of module 2.5 submitted under IND XXX,XXX."

Is this acceptable?  My position is that since this is a Mod 2 document and, therefore, a global eCTD component, we should not be cross-referencing to an IND in the US that ex-US health authorities would not have access to (in other words, this cross reference is useless for HAs outside of the US).  I'd like to ask the RegEx community for your input on this approach.

Many thanks!

For IND lifecycle maintenance, i would prefer to submit a standalone document for 2.5 in the new IND - this is a cleaner approach. In the event that the old IND you make the cross reference to is withdrawn, then you will have to resubmit 2.5 to the new IND.

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Katrina Chan
Manager, Global Regulatory Affairs
Berkeley CA
United States
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Original Message:
Sent: 07-Mar-2022 10:42
From: Anonymous Member
Subject: Module 2.5 - Clinical Overview - cross-referencing strategy

This message was posted by a user wishing to remain anonymous

Hello,
I work with a company whose historical approach to writing M2.5 for a new IND is to cross-refer the FDA to already-open INDs for the same drug.  For example, instead of providing summary text on the biopharmaceutics or clin pharm sections, the medical writers are cross-referring the FDA to previously-submitted informatoin by stating: "Please refer to the clin pharm section of module 2.5 submitted under IND XXX,XXX."

Is this acceptable?  My position is that since this is a Mod 2 document and, therefore, a global eCTD component, we should not be cross-referencing to an IND in the US that ex-US health authorities would not have access to (in other words, this cross reference is useless for HAs outside of the US).  I'd like to ask the RegEx community for your input on this approach.

Many thanks!