RE: Medical Writing Style Guides and books (references)

[Dan Goldstein <DGoldstein -at- nuot -dot- com>]

For medical devices, there's no agreed-upon style guide. FDA and Notified Bodies (for international sales) don't dictate comma usage, margins, fonts, etc. Just make sure it's easy to read.

Having said that, you *do* need to use their terminology (CAPAs, complaints, etc.) -- or else have a terrific justification for not using it, along with a glossary.

-----Original Message-----
From: Janoff, Steven
Sent: Tuesday, October 27, 2015 3:51 PM
To: techwr-l -at- lists -dot- techwr-l -dot- com
Subject: Medical Writing Style Guides and books (references)

Hi Whirlers,

For those of you writing in any of the medical/bio fields -- biomed, pharma, biotech, and especially medical devices -- do you have a "bible" or is there a universally (or almost so) agreed-upon style guide for this field?

I know there's AMA, and I've seen, what is it, CBE or something.

Also, do you have any favorite books on medical writing that you could recommend?  Other resources?

This applies to both tech writing (package inserts, user guides, IFUs -- "labeling") as well as to marketing writing (usual stuff).

I'm in the field and I want to get more accustomed to the particulars of this type of writing.

Thanks so much for your advice.

Steve

PS - A lot of it is regulatory, some is not.  I don't know if the FDA favors one guide or another, but I'm sure some of you know.  The regulatory aspect is a side issue but important.  I'm mainly interested in style choices.

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