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  Comparative therapeutic claims of schedule 2 products in DTC setting
  J Jennifer Carroll

  Hey @Username
  “Schedule 2” is a bit broad. There are many factors and combinations to consider. Could you provide the product or therapeutic class, or Federal drug schedule (see link) to help narrow down the response. Alternatively, if you’re not comfortable sharing in a public space, you can email review@paab.

  DTCA/I, consumer secondary audience

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  RWE Data presentation
  M mef

  Hello,
  Can you please clarify for RWE study presentations, if the footnotes (e.g. for study design, etc.) need to appear within the grey box and hence, before the fair balance - or after the fair balance (which would place it outside the grey box?) We have received two slightly different directions from PAAB on the placement of RWE study footnotes. Thanks.

  Claims & Support/References for Claims

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  Pre-NOC storyboard review
  J Jennifer Carroll

  Hello @Jennifer-Thomson
  It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval.

  General Discussion

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  RAMQ criteria vs. notes
  J Jennifer Carroll

  Hey @ALee
  The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included.

  PAAB Code

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  Update - Changes to the eFiles submission form requirements
  J Jennifer Carroll

  Hello @manufacturer @agency

  Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact.

  What's changing?
  PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact.

  Click here to more about why, new form requirements, and what this means for the review process.

  Question? Post below and we'll get back to you.
  Thanks
  PAAB

  Announcements submission