YOUR QUESTIONS? ALL ANSWERED
Ask PAAB is a question-and-answer system that allows you to ask questions anonymously to PAAB. They then post their answers in this archive on a periodic basis. If your question requires more immediate attention, we encourage you to contact PAAB directly. Please ensure that you ask your question in English. To view the PAAB Code of Advertising Acceptance, please click here.
Questions updated to: October 4, 2021
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As references are not typical in patient information materials, do patient website submissions to PAAB require referencing?
For review purposes, PAAB requires the copy deck to have references in order to validate the copy. The published website does not require references.
Is it acceptable to put a Sales Representative image as part of a VAE signature? So at the bottom of the PAAB approved email.
The PAAB logo is presented on pieces that are approved by PAAB. Any alteration to that piece, renders the display of the PAAB logo invalid. It should be submitted for re-review with a placeholder for the reps image. Please reach out to PAAB with the specifics of the eFile in order to determine next steps.
This question relates to PAAB code 3.2.3 (information on ongoing trials)
Q1: Can you please confirm the elements that can be included in an APS - Study design, objectives, endpoints?
Q2: We are assuming that when the code states 'ongoing' it means prior to an NOC which includes a trial that is no longer recruiting but collecting data.
Q1: Yes, study design, objectives and endpoints, can be presented in a non-promotional manner per code section 3.2.3. Remember that the study must still be in the data gathering stage, with no interim analyses having been performed (including safety analysis), and it must be disclaimed accordingly.
Q2: Please see Q&A 537 and Q&A 223.