The new FDA RTA (Refuse to Accept) Guidance

Z

zmimshen

#1
Hello all,
Just wondering if anyone has had any experience with the new FDA Refuse to Accept Guidance?
Is it being implemented yet?

Any info is much appreciated.
 
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M

MIREGMGR

#2
I don't have any direct experience yet, but:

A 45 day stakeholder comment period began on August 13, 2012. My knowledge of past practice in regard to draft Guidances has been that they are not applied until after the comment period, but sometimes (usually, in my observation) are applied (sometimes selectively) after that comment period, even though nominally not converted from a draft Guidance to an adopted or finalized Guidance.

FDA has some guidances that appear to permanently be in draft state, for various reasons including political considerations.

So, my assumption would be that FDA might begin applying the new Guidance no sooner than roughly next Monday.
 
W

wcraycroft

#5
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
 

Attachments

Wes Bucey

Quite Involved in Discussions
#6
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
Actually, most first line reviewers for government agencies seem to need the dots connected very plainly or they simply jump to a wrong conclusion because the specific documentation they are looking for is not in the place where they are used to seeing it. Filling out a reference checklist to accompany a government agency submission is a very common recommendation made for years by consultants to companies under FDA or FAA regulation.

Personally, I think the problem of errors and omissions by regulatory agency reviewers is due to these main factors:

  • submissions are not subjected to rigorous internal editing and review BEFORE sending to the agency - the writer makes the error of ASS-U-ME by thinking a reviewer will instantly follow the writer's intent, regardless whether the required elements of documentation are present.
  • the average agency reviewer has no benefit in spending time trying to fill in gaps or interpret intent - he/she has only two choices: (1) accept or (2) reject (based on a single reading) - the second reviewer has the advantage of having the omissions or shortcomings flagged and may spend a little more time parsing poorly written statements by the submitting company.
Bottom line:
submissions should include and follow a checklist which connects all the dots - remember that, unlike a 3rd party registrar, the government agent is NOT directly paid by the submitting company and does NOT have any stake in maintaining friendly relations with the auditee.
 
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