Now that the RTA guidance is final (December 31, 2012), and the RTA Checklists are being enforced, we submitters are being strongly encouraged to include a copy of the appropriate checklist right in the submission. The copy should be annotated with the exact location in the submission -- page, section, etc -- of each item in the checklist that is included in the submission, or the rationale why it is not included.
My question to the forum is does anyone have a writeable copy of the checklist? (I haven't tried Adobe yet; the pdf guidance document should be unprotected, I would think.)
By the way, the FDA audits the RTA process quarterly. The audit shows the failure rates for the RTA checklist review, and which items are missing. The audit also calls out cases where the checklist reviewer was in error (e.g., fell into a substantive review, which they are not supposed to do) I'm attaching the February - April 2014 audit results.
I've found other quarterly audit reports buried in FDA MDUFA quarterly meetings. You have to hunt for them ...
Best,
Warren