PAAB offers a Written Opinion Service designed to help clients understand the PAAB Code better, make compliant decisions and to provide direction during project development. Opinions can be requested:
- To clarify what is advertising subject to the regulations
- To clarify exemption from review
- To receive guidance on the acceptability of concepts
- To clarify linkage of material
- To receive guidance on the acceptability of references for product claims.
- To clarify contextual issues
Only one opinion letter is provided per opinion submission. If clarification is needed about anything written in that letter, the PAAB review staff will respond to requests by telephone. 5-10 minute calls are generally sufficient. Final approval would be provided only after completion of pre-clearance review.
Why consider a Written Opinion:
- Opinion submissions provide clear, written guidance on the direction of proposed pharmaceutical advertising and promotional materials.
- Through a timely, confidential review process, PAAB offers opinions to help stakeholders assess the use of studies, guidelines, or understand how specific concepts or executions may align with the PAAB Code, supporting compliance and reducing regulatory risk early in development.
The details:
- Mode: Submitted via eFiles by client in written format
- Output: Written opinion response
- Timing: 4-day turnaround time from time of submission.
- Fee: See the associated fee
here
- Scope: Opinion submissions provide clear, written guidance on the proposed pharmaceutical advertising and promotional materials activity presented.
