341 - If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review? Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.
Jennifer Carroll last edited by
If the scenario outlined in your question occurs, the first course of action is to discuss the issue with the reviewer of record. After that discussion, you have an option to contact Senior Reviewer Preclearance Services to discuss whether the perceived inconsistency is an actual inconsistency and how to move forward. This allows you to get to a resolution more quickly, and it helps PAAB to address consistency issues. The PAAB reviewers write around 20,000 letters per year and historically real inconsistencies are few. The PAAB struck an industry member committee to investigate consistency during the review process and found that the PAAB has a systematic process to address inconsistency. The board will decide if an audit recommendation will be approved. Thanks, Ray.