I have been reading the new guidance from the FDA on distributing reprints while preparing a Regulatory Alert, which should be released on Monday or Tuesday. One thing that really stood out to me is the change in the background section.
The background section from the 2009 final guidance had a three-paragraph section lasting less than one page. By contrast the new guidance has a background section that spans five pages and 15 paragraphs, with almost as much contained in footnotes detailing the legislative history as in the guidance itself.
This document definitely reads to my eyes far more as if it were written with the intention of being defended in a court of law than the 2009 version.
I'd love to hear from anyone who had a similar impression.