Total number of client tags (prior to validation)

Tag submitting company and manufacturer distribution

Therapeutic area distribution

Total number of tags deemed valid following internal review

Validated tag breakdown

Q4 PAAB Action Taken:

The “Incomplete review unwarranted” tag brought to our attention a review practice sometimes used when content is identical across multiple submissions from the same submitter. In these situations, reviewers may reference comments provided in another file and ask the client to apply them accordingly. While this approach is intended to improve efficiency, we recognize that, without full context within the specific submission, this may be perceived as an incomplete review.

To address this, reviewers have been asked to repeat comments across individual files, unless the submissions are formally structured as series or child files. This is intended to ensure clarity and completeness within each review.

In one instance, “late correspondence” also affected the review process. The reviewer did not identify in the initial round that the submission had not been segmented to clearly capture all intended iterations. This highlighted an opportunity to further clarify expectations around email fragment submissions. PAAB will consider adding examples to its submission guidance to illustrate when email fragments may be treated similarly to modular or series submissions rather than as variable-field submissions. In addition, PAAB will reiterate with the administrative team the importance of identifying fragmented submissions at intake and advising clients promptly if the submission structure requires clarification.

Regarding tags that were not validated:
A trend observed this quarter involved inconsistencies between the tag selected and the outcome of the file. For example, if a tag indicates that an objection was maintained despite prior approval for the brand, but the content was subsequently approved once relevant backfiles were provided, this tag would not accurately reflect the outcome. In such cases, the criteria for the tag are not met, and the tag would not be validated.

Q3 PAAB Action Taken:

Two tags were received this quarter, and both were deemed valid.

One ticket related to a late-stage comment, which was acknowledged by the reviewer in the response letter. As a reminder, reviewers are asked to consult with a Director before issuing any late-stage comments. PAAB continues to make every effort to minimize these occurrences. We appreciate the tag, as it helps us track and identify potential trends over time. Thank you to the submitters for taking the time to share this feedback.

The second ticket involved a comment being overturned after previous files were confirmed to be within the same context. In this instance, the review team was reminded that a clear contextual difference must exist between previously approved copy and new copy in order to challenge. If no such difference can be clearly identified, the copy should remain unchallenged.

Reasons for not validating a tag:

No invalid tags this quarter.

Please note that tags are one of the most effective ways for clients to share constructive feedback and help strengthen our review process. They enable us to recognize best practices, identify opportunities for continued growth, and ensure greater consistency across the team.

We warmly encourage clients to take a few moments to submit tags in real time — sharing clear, tangible examples helps us continuously improve and enhance the overall experience for everyone involved.

Q2 PAAB Action Taken:

While no consistent trends were observed across this quarter’s tickets, PAAB continues to use each one as an opportunity to reinforce best practices with the Review team.

The tickets prompted a helpful reminder around the importance of avoiding late comments. While we strive to prevent these entirely, we recognize that on rare occasions they may occur. In response, Reviewers discussed practical ways to help minimize the impact on clients, such as prioritizing the review upon resubmission, offering to jump on a quick call, and being as clear and specific as possible about the nature of the comment and potential solutions.

Reviewers also discussed how to enhance the clarity of their guidance overall. This includes providing concrete examples, direct links to relevant guidance documents, and references to precedent files. These help to better explain both the rationale for the request and how to address it in revisions.

Reasons for not validating a tag:

The invalid tags this quarter had a trend in misunderstanding of PAAB Code guidance documents by the submitter. This led to the submitter perceiving there to be a lack of expertise. Evaluation of the initial guidance and final ruling uncovered no lack of expertise. 

Q1 PAAB Action Taken:

In one case that resulted in two tags, a piece was reviewed based on the pre-NOC Product Monograph. When the NOC was granted, the monograph had changed and no longer supported the claim in question. However, the reviewer did not identify this update and proceeded with the review. The discrepancy was later caught in a subsequent submission and addressed at that time. This incident prompted a reminder to PAAB staff during a reviewer meeting to carefully assess any changes between pre-NOC and NOC Product Monographs, as such changes may impact the validity of previously reviewed content.

Several tags also led to one-on-one follow-ups with reviewers to address, in general terms, clarity of written correspondences with respect to intent and accuracy of comments and the precision of code application. As part of this process, the team was reminded to refer to previous layouts when applicable, and to guide clients to supplemental documents when they can provide a clearer explanation of how specific code sections apply.

Reasons for not validating a tag:

We’ve observed a recurring issue with the use of the tag: “The requested revision was unclear to me even following a clarification phone call.” In several instances, no corresponding call is documented in the eFile. Please note that this tag is only valid if a call has actually occurred. Be sure to use this tag only after a clarification call has taken place.

Additionally, some tags marked as “Perceived issue with level of expertise” were deemed invalid. In these cases, the reviewers' feedback was accurate, and the resulting changes were appropriate. Upon review, it appeared that clearer explanations or more precise references to relevant guidances/advisories may have helped improve understanding for the client. Reviewers have been reminded to provide specific rationale and direction to support clarity.