reference format for FDA and EMA guidance documents

Can anyone explain how to create a record for and FDA guidance document and a European Medicines Agency (CMPM) guidline document? Ideally, I would like a pointer to a downloadable reference. Next best would be a copy of a completed record that I could use as a model for entering the bibliographic data manually. At a minimum, what is the correct Reference Type for this sort of document?

If you gave us some more detailed examples, we could test some things. 

After a couple false starts, I googled Google for some bibliographies on the FDA site, found one I thought was a guidance document and then checked Google Scholar for it – so I had found links to “Guidance for Industry: Waiver”  and was able to download a not too bad reference to endnote from there. (searched scholar and then selected that top "citation match in the 2nd attachment, which led to the view in the 3rd attachment, with the “cite” hyperlink which opens the download menu shown). 

It came across to Endnote as a “generic” reference type with the FDA author on several lines when it should be one, and wtih an odd character in it, but it was easy to fix.  removing the line breaks and adding a trailing comma to the end. 

this was formated by my “cell” output style pretty well, without even changing the ref type to anything else?

Food Drug Administration Center for Drugs Evaluation Research (2000). Guidance for Industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage. Forms based on a Biopharmaceutics Classification System (FDA Maryland).

The field assignments are shown in the GIF attached. 

You can change it to a ref type of “Goverment Document” I suppose, but since most output styles don’t have a template for that, it still uses the “generic” one.  You could create and add additional field info, if it is missing some of what you want, and then copy the gereric and adjust for the output you are hoping for. 

Looking at some of the bibliographies from the FDA site itself (like here)might give you some more ideas about how to construct the citations you would need.

Is this kinda what you are looking for?


Yes this is what I was looking for. Thank you so much.

I apologize for taking 2 days to respond. I thought I would get email to notify me if anyone responded. I may have neglected to check the box. I ujust joined the forum, as I may have said in my original posting.