A quarterly review of the eFiles tag report 

Total number of submissions*

*Refers to unique eFiles. This number does not account for iterations within each file.

 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

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.

Is there more information you would like to know and see in the next quarterly update? Let us know on the Forum.