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PAAB's Accelerated
Preclearance Pathway (APP)
A new service intended to reduce
the time to approval |
Please provide
feedback by April 14
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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.
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We need your views by April 14PAAB 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.
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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.
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Quicker response time for initial reviewYou can choose from 2, 4, or 7 business days depending on your budget and urgency.
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Quicker response time for subsequent revisionsResponse within 2 business days
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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.
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Click to set custom HTML
(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. )
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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.
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(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.)
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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.
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(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).
PAAB’s current and proposed offering
Accelerated Preclearance Pathway (new)* |
Current |
2 |
4 |
7 |
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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 |
No |
Yes |
Yes |
Yes |
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No |
Yes |
Yes |
Yes |
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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
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Please provide feedback by
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