RE: Medical Writing Style Guides and books (references)

["Janoff, Steven" <Steven -dot- Janoff -at- hologic -dot- com>]

Thanks, Dan.

Yeah, I haven't had a CAPA yet but they're out there.

I was actually thinking more in terms of writing style rather than mechanics, e.g., not so much punctuation or nitty gritty but more "voice" and style.  I don't mean anything like "flourish" but... it just seems like there's something different about medical writing style as opposed to for example software user guide style (although some of the docs are in fact exactly that).

But I guess a style guide *does* in fact deal with mechanics so AMA or CBE or whatever would likely specify those kinds of things.

I know from what I've seen so far it's a very factual, scientific style but then again so is any kind of technical documentation.  I think you know what I mean but it's just hard to express in words.  (I thought I was a writer, eh?)

Thanks,

Steve

PS - Maybe it's just the subject matter that gives it a different tone.


On Tuesday, October 27, 2015 12:59 PM, Dan Goldstein wrote:

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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