About the Accelerated Preclearance Pathway (APP)

APP will complement the existing preclearance pathway. When launched (date tbc), APP will be available for a subset of submission types. Over time, APP will cover all applicable submission types. This gradual increase will provide PAAB the opportunity to scale staff, technology, policies and procedures, ensuring you receive a consistent high level service.

We need your views by April 14

PAAB would like to gather your feedback on the proposed APP service. At the bottom of this page is a short survey about the proposed offering outlined below. Your responses will be anonymous unless you’d like to be contacted about the service at a later date. 

Feedback

Welcome to the App

The proposed new service is intended to reduce the time to approval through five separate but synergistic mechanisms.The 5 points, along with pricing, as noted below are still being finalised.

​Quicker response time for initial review

You can choose from 2, 4, or 7 business days depending on your budget and urgency.

Quicker response time for subsequent revisions

Response within 2 business days

What do you mean by "decoupling of submission elements"? The ability to obtain official rulings for select parts of an ongoing submission rather than needing to wait to resubmit the entire revised copydeck/layout. These decoupled interim rulings are provisional only on the final context. This means that these interim rulings can be considered firm so long as revisions made in the context of the decoupled elements, upon resubmission of the revised entire copydeck/layout, do not render the ruling inapplicable.

What do you mean by "asynchronous messaging"? This refers to a virtual conversation in which the conversing parties are not required to be concurrently active or present.

Decoupling of submission elements for additional collaboration through asynchronous messaging with your reviewer.

A. Via a messaging functionality directly on your submission, you’ll be able to obtain a provisional ruling for select parts of an ongoing submission. Removing the need to wait and resubmit your entire revised copy deck/layout and resubmission letter.
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B. These decoupled interim rulings are provisional only on the final context. This means that these interim rulings can be considered firm so long as revisions made, are acceptable in the context of the other decoupled elements and vice versa.

Submission

The following image is the post-gate homepage of the fictional prescription product Verant. It is part of the initial submission of the website submitted to PAAB for review. Although our clients typically submit copydecks initially, we are illustrating the layout to make it easier for readers to follow along.

1st Rewview

Following PAAB's initial review of the website, the client receives the PAAB comments embedded directly into the PDF. This is a dynamic PDF. Clicking on any of the annotations within the ad copy highlights the corresponding comment in the notes panel. Alternatively, clicking on a comment on the notes panel generates a line pointing to the corresponding annotation in the ad copy. Long story short, the client always knows precisely which phrase, word, image element, or syllable EACH revision/clarification request pertains to. The comments are always in context. In this case, the PAAB reviewer was Nikki.

Client Q

Having carefully read the revision requests pertaining to this homepage, Hosea (the client), wonders whether he has a viable solution to the issue pertaining to the convenience claim. Needing to be confident on how to proceed, and knowing that PAAB does not provide rulings over the telephone, he sends a message directly to the reviewer by clicking the note to reveal the "reply" field he'll populate prior to clicking "send". Because he included an @ command, the reviewer will automatically be notified of his question. It's that easy!! He had the option of appending an image to his added annotation (i.e., to show exactly what the revised layout would look like), but he elected not to as a quick text explanation along a drawn arrow conveyed his proposed solution clearly enough. Here is what the reviewer sees upon clicking on her notification alert:

PAAB Answer

Within 24 hours, the reviewer responds that the agency's proposed revisions would not quite address the issue. She elaborates on the issue and proposes a solution that builds on Hosea first attempt to address the issue. Here is what Hosea sees upon clicking on his notification alert:

Client Q2

Hosea now understands. He elects to ensure that his understanding is correct before getting the designer to update the layout. He sends the reviewer an updated description of how he'd like to address the issue. This is what the Reviewer sees:

PAAB Answer 2

The the reviewer responds again within 24hrs. She confirms that the proposed fix is acceptable.

(These rulings on client selected elements of the submission will be provided over an asynchronous messaging functionality which will be integrated directly into copydecks, layouts, and video on the eFiles submissions system.  PAAB will respond over this system within 24 hours (on business days). Implementation of this functionality does not prevent clients from engaging with reviewers over the phone in a scheduled live discussion. )

Access a second opinion from another reviewer in your therapeutic area.

​To help you check that a ruling is both accurate and consistent early in your review process,  you can now request a second opinion after the second PAAB correspondence on that particular matter.

(This service will only be available as part of the APP, as it utilizes new messaging functionality embedded directly onto the submission. A second opinion may be requested in a client correspondence explaining why they disagree with the reviewer's position after the second PAAB correspondence on that particular matter. As each communication over the messenger counts as a "correspondence", the second opinion is available very early in the review process.)

Earlier access to the escalation process with the Senior Reviewer of Preclearance Services.

​As your communications over the messenger counts as a "correspondence", the escalation becomes available to you very early in the review.

(Escalations will continue to take place over the telephone (or web-conferencing). Escalation must be requested in a correspondence explaining why the client disagrees with the second opinion. As each communication over the messenger counts as a "correspondence", the escalation becomes available to the client very early in the review (in contrast to the standard preclearance pathway where only written letters are available as official correspondences).

Please provide

feedback by April 14

Feedback

PAAB’s current and proposed offering

Accelerated Preclearance Pathway (new)*

	Current	2	4	7
Cost single language	$390	$585	$780	$1170
Cost multi language	$450	$675	$900	$1350
1st response guaranteed	10 days*	2	4	7
Subsequent response time	3 days	2 days	2 days	2 days
Decoupling submission	No	Yes	Yes	Yes
2nd PAAB opinion	No	Yes	Yes	Yes
Escalation timing	After 13 days	After 4 days	After 8 days	After 9 days

​*pricing and service features may change ahead of the launch. View current levels here 3 Levels of APP

Please provide feedback by
April 14.

• Your responses are anonymous unless you state otherwise.
  
• Within the survey will be an opportunity to register interest in being amongst the 1st to use the APP.