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  3. Submission Requirements/process & Timelines/eFiles

Submission Requirements/process & Timelines/eFiles

34 Topics 48 Posts
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

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  • Jennifer CarrollJ

    307 - With more 'digital detailing' from reps to physicians using iPads and tablets, many software platforms offer the ability to re-order slides in a presentation. As PAAB approves these materials do they approve them in the order reviewed only, or as individual slides / videos etc that can be re-ordered by a drug company without further approval?

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  • Jennifer CarrollJ

    294 - Hello, I have a piece that is being reviewed and will likely be available before my required date of 1st use. Is it possible to align the PAAB expiry with the timing of use of my piece.

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  • Jennifer CarrollJ

    281 - Please confirm the approval process for French websites. We submit the English copydecks and layouts for approvals. Once approved, we then submit the French copydecks for approval. Does the French copydeck require French layouts or can we submit the French copydeck with the English layout?

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  • Jennifer CarrollJ

    279 - Dear Concern, What are the time lines and submission procedures in canada. what are the guidelines for OTS products in Health Canada (submission only)

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  • Jennifer CarrollJ

    244 - 1. Is there a preference as to which comes first after a claim: the symbol (e.g. *) or the footnote number (e.g. 1)? "My product was tested and found to work."*1 or "My product was tested and found to work.1* 2. Should these be superscripted or just keyed in in a regular font (e.g. *) 3. Is there a separation required between footnote numbers and symbols? "My product was tested and found to work."1,* In AMA (American Medical Association) format the reference number would come first, separated by a comma, then the footnote symbol. The referencing would be superscripted. "My product was tested and found to work." 1,*

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  • Jennifer CarrollJ

    198 - Dear PAAB, We have been asked to prepare a slide presentation for our sales reps to use for group presentations to customers. These events vary in length from 20 to 60 minutes. It is not possible to create a separate slide presentation for each event. We propose a 'core' deck with the essential safety and efficacy information, and an 'enhanced' or 'expanded' deck with additional published data. Both would be PAAB-approved. In cases where there was insufficient time to present the larger presentation, the core slides would be presented and would be supplemented with a number of slides from the PAAB-approved 'expanded' presentation. Is it possible to use 2 approved slide decks in this manner? If so, how should they be submitted to PAAB for approval. Thanks for your interest.

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  • Jennifer CarrollJ

    161 - My submission now has the status "Response Required". How do I see the details behind this status? When I click on my submission, I only see the original submission and documents and no indication of what revisions or additional documents are required.

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  • Jennifer CarrollJ

    147 - I would like to understand what the average time (weeks/days) the PAAB currently are working to with respect to the review and approval of promotional materials from pharmaceutical companies

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  • Jennifer CarrollJ

    145 - When is the time one can submit a docket before the Holidays? Are you open between Christmas and New Year's? If so, do you accept submissions at this time? Also, does the rule of 2 for initial docket submission still apply? Is the queue always 10 days for every first submission within that docket?

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  • Jennifer CarrollJ

    117 - I presently manage a small graphics studio and printing company and have been asked by one of my clients to arrange to get PAAB approval for certain Pharmaceutical Detail aids, Brochures and other related materials. I would like to know how to go about registering either my company or myself to be able to submit to PABB for approvals in the near future.

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  • Jennifer CarrollJ

    109 - Under the current system, PAAB surveys are sent to the administrative staff who perform the work of submitting efiles. Can they be directed to the creative staff who perform the work of writing and responding to the letters?

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  • Jennifer CarrollJ

    107 - For a launch product is the review time the same as an old product line. When a pharmaceutical submits to PAAB the promotional pieces needed at NoC does PAAB take their 10 full days for review or is it possible to take half of the time because it is a product in launch mode.

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  • Jennifer CarrollJ

    27 - We recently made a complaint to PAAB about a detail aid which our competitor is using, as the detail aid is not PAAB-approved. We have heard nothing in response, and are wondering what we can expect from the process.

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  • Jennifer CarrollJ

    23 - How do you know when to submit an APS as a Detail Aid APS (s. 6.3) or a Service-Oriented Vehicle (s. 6.4)? Are there characteristic hallmarks that tell you which way one should go?

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