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I'm currently working on a paper along with some folks from a certain school in Cambridge and others in industry. We are working on having it completed in the next few weeks, with a submission deadline of late November for potential inclusion in a journal (won't hear back on that front till late December.) My question is, would it be appropriate to include this on an ED application due mid-November? This would be my first ever publication and the topic (regulatory-related) is very much germane to the remainder of my application.

It seems that you're putting the cart a bit before the horse.

Because, if you DONT get it published, and your resume says you did, it wont be the end of the world, but it wont look great.

I'd mention it in your personal statement or something, and add in a caveat along the lines of "potentially published in x journal."

You can list it on your resume this way:

"Title: Whatever It Is" (under review at Journal of Whatever).

That's what you do when you want someone to know you wrote something and are trying to getting it published, it just hasn't happened yet.

Since you mention you don't have any other publications, I would probably list it under "Papers" rather than under "Publications." If you have other research-y type experience, you might be able to lump it with that if you don't want it sitting out in a section all by itself.

I would cite the would-be publication formally and put "manuscript in preparation" behind it. That's what I did for my publication in college. I don't think it's odd since you are just a college student getting your first publication. It is actually quite an achievement.