There's a lot of background action going on and many of us are scheduling meetings with FDA/OMB. BUT... It's all guess work to a point. We can go in and say what we want, what we expect and what we think the proposed regulations will do to our industry but we have only vague ideas of what the other side is really doing (yet). We can speculate all we want but it's really all about presenting ideas for what we believe to be reasonable and fair regulations hoping that they'll be considered and acted upon before final regulations are created.
I did learn an interesting tidbit and that is that anytime there is a comment period on a fda regulation, clarification, rulemaking or whatever, only comments submitted on that proposal can be included if the fda were ever taken to court. New evidence cannot be added. I had a totally different picture of the documentation I'd bring.. Now I post it in advance..
Comment on and keep up the good fight.
hoog