Make sure you send this to Missling and the companies email address.
Biotechnician, My expectation is that Dr.M. helped design-guide this change. The fact that it took these guys 5 years to produce the doc after the guidance draft should tell us something. The FDA has some of the best process people and practice managers on the planet. BUT, they cannot get out of their own way once you get more than 3 of them in a room. Additionally, the cross linked functional matrix/ top heavy structure presents a fine weave which is almost impossible for change to penetrate.