Introducing NEW PAAB Consultation Services
PAAB is pleased to introduce a set of enhanced consultation services designed to make it easier for clients to engage with us early and often throughout the development and review process. These services provide flexible, timely access to PAAB expertise, helping you anticipate issues, reduce rework, and move forward with confidence.
Then and now?
For some submissions, the traditional approach may have been seen as reactive, sequential (wait – revise – resubmit – wait again) and fragmented (changing copy in one location often impacts others).
These offerings shift the experience to proactive, integrated and time-efficient at the client’s discretion.
Rapid Access Consults
“We need a quick, focused answer now so we don’t go down the wrong path”
Rapid Access Consults offer fast-turnaround feedback from a team of two reviewers on targeted questions or materials. This service is designed for situations where speed is critical and focused regulatory insight is needed quickly. Click to see the fee schedule.
Intra Review Consults
“We want to fix issues or attack complex revisions before they turn into delays”
Intra Review Consults allow clients to share screen with a team of two reviewers and problem-solve with PAAB while a submission or review is already underway. These consults help address questions, clarify expectations, and resolve issues before they escalate. Click to see the fee schedule.
Product Monograph Consults
“We want to build regulatory expectations into our plan”
The Product Monograph has broad and significant implications for the is the basis for claims that can be made in drug advertising. Product Monograph consults support proactive project management by aligning regulatory considerations with your desired key advertising messages. This service helps teams integrate PAAB guidance into broader planning and execution and helps improve the predictability of timelines at launch. Click to see the fee schedule.
In addition to these new services, keep in mind our other services to enhance collaboration with PAAB:
Messenger
“We want quick, binding feedback on pivotal segments of the APS prior to resubmission ”
Messenger provides quick, informal access to your reviewer for clarification on specific questions. It’s ideal for early-stage thinking or minor issues where timely guidance can keep projects moving. Click to see the fee schedule.
One-Hour Consults
“We want to plan ahead and get detailed feedback on a key issue”
One-hour consults provide a structured, in-depth discussion on defined topics. They are well suited for strategic questions, interpretation of guidance, or planning next steps. Click to see the fee schedule.
Written Opinions
“I would like written feedback on a key issue before implementing something across a campaign”
Opinion submissions provide clear, written guidance on the acceptability of proposed pharmaceutical advertising and promotional materials. Through a timely, confidential review process, PAAB offers opinions to help stakeholders understand how specific concepts or executions may align with the PAAB Code, supporting compliance and reducing regulatory risk early in development. Click to see the fee schedule.
Clarification Calls
“I need some clarity on a review issue identified in my letter”
Clarification calls are short, 10-15 minute clarification calls that happen within the context of a specific comment with your reviewer. These are included within the cost of the review and should be limited to one call per round of review. Clarification calls are used to clarify points in your review letter to help move the file forward and reduce rounds of revision.
Escalation Calls
“I need a final, binding ruling on a key review issue”
PAAB escalation calls are calls with the Director of Preclearance Services intended to address review issues that have reached an impasse. Please note that escalation calls should only be requested after attempts have been made to resolve issues in writing and over the phone with the primary reviewer on the file. See section iii.
General Questions
“I have a quick question on general PAAB guidance”
General questions are 5-minute, non-billable calls where reviewers can explain the meaning of existing PAAB guidance as it relates to general scenarios.
Forum
“I want to connect with industry peers and have discussions on PAAB topics”
The forum was created as a space to build a community where members can learn from one another, share perspectives, and build a collective understanding through open discussion. As the community has grown, so has the depth of experience and insight within it.
To better support that original intent, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share their experiences, and help unpack questions together.
This means you may notice more space for peer-to-peer conversation before PAAB weighs in. That’s intentional. Some of the most valuable insights come from real-world application and shared interpretation. PAAB believes this forum is uniquely positioned to surface that collective knowledge.
PAAB will continue to actively monitor discussions and will step in to:
Clarify or correct any misunderstandings
Provide guidance where questions remain unanswered after a few days
Support the conversation when official interpretation is needed
Our goal is to grow a collaborative, trusted community where knowledge is shared, confidence is built, and learning is continuous. Leaning into collective knowledge supports the growth and development of the industry.
Thank you for contributing your expertise, curiosity, and perspective. This forum is strongest when it reflects the voices and experiences of the community itself.
Together, these services are designed to support ongoing dialogue with PAAB—helping clients engage earlier, consult more often, and navigate the review process more effectively.
@Agency @Manufacturer
