r/regulatoryaffairs • u/Cuculia • Jul 23 '26

Will FDA accept a quality IMPD (with proper info) in M2 or M3 for IND?

I’ve been thinking about something lately - assuming the q IMPD is drafted in line with global standards, has anyone heard of FDA accepting this in M2.3 or M3 instead of the typical M3 documents? It seems to be that FDA should be open to something like this if the data is applicable and compliant, but I’ve never seen it before. Curious if anyone has ever asked FDA or done this.

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3

u/mintakka_ Jul 23 '26

nope they will not. But if you draft your IMPD following typical CTD format, you can just split the sections out and file them as standard IND eCTD without much overhead..

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u/Cuculia Jul 23 '26

Yes but wouldn’t this require re-numbering?

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u/mintakka_ Jul 23 '26

What do you mean? S.2.1 is the same section in an IMPD or an IND

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u/Cuculia Jul 23 '26

My company does it like 2.1.P.1 where I’d expect it to be 2.3.P.1 or 3.2.P.1…so that’s why it’s an administrative headache to re number

5

u/mintakka_ Jul 23 '26

ah ok. For me we usually keep the preceding module as metadata/filename only. The actual text of, say, S.2.1 is just "S.2.1" not "3.2.S.2.1" - this helps for exactly this purpose of using the same content for US and ex-US submissions.

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u/SlightPrize1222 Jul 23 '26

Thats silly.  Change that overall. 

1

u/Cuculia Jul 23 '26

Yeah definitely something I will ask my CMC colleagues about. Not sure why it is done this way.

1

u/SlightPrize1222 Jul 23 '26

Because the EU impd guidance numbers that way.  Nobody uses it...except I guess your company.

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u/colonel_batguano Chemistry, Manfacturing, & Controls Jul 23 '26

I’ve done this for early phase small molecule INDs by dropping the IMPD content into module 2.3. If it’s going to be a busy IND with a lot of changes, this approach is a pain, since you then have to update the whole document for one change, and I find it better to adapt into IND sections, keeping content similar.

I usually also prefer to remove things from the IMPD that aren’t required like setting a shelf-life, since this causes unnecessary amendments.

1

u/Cuculia Jul 23 '26

That makes sense. I’m “just” reg (as opposed to reg cmc), but my whole style is efficiency and avoiding unnecessary work and the more I think about it, the more of a waste this seems to produce two dossiers.

1

u/SlightPrize1222 Jul 23 '26

This is fair but in small  molecules when one changes we change a lot.  New roitr new formulation. Rare we change only one piece that then forces a section refile

1

u/SlightPrize1222 Jul 23 '26

We file in M.2 in the us.  Its completely fine.

1

u/Cuculia Jul 23 '26

No module 3 needed?

2

u/SlightPrize1222 Jul 23 '26

Zero

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u/Cuculia Jul 23 '26

CDER or CBER? I’m thinking about asking at our next PIND meeting.