Back in June, I did a posting (see http://sstrumello.blogspot.com/2008/06/fda-needs-your-input-on-islet.html for that) which indicated that the FDA Needs Your Input on Islet Transplantation. The deadline is officially today, although anyone may comment anytime on guidance, if you wish your comments to be seriously considered, try to get something by today.
The main issue seems to be that the guidance is based largely on out-of-date protocols which no longer seem as relevant today as they did when they were first prepared back in the late 1990’s. Of note: the arbitrary cutoff of stimulated C-Peptide of <0.3 ng/mL. This is not only out-of-date, but also unnecessary, since researchers may be more restrictive if they’d like, but should not be constrained by illogical FDA guidance. Please comment!!