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    • A

      PAAB Exempt - Coverage/Reimbursement APS
      • AU3010

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      Jennifer Carroll

      Hello @au3010

      We would need to see the whole piece to make an assessment. We suggest submitting for an exemption request.

    • I

      Advise on a symptom tracker app; does this need PAAB review?
      • IainB

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      Jennifer Carroll

      Happy Friday @iainb

      A symptom tracker that relates to a disease and not medication AE’s or medication outcomes, which contains no branding elements, could be considered exempt if there was no mention of treatment. If the tool speaks to treatment (even in an unbranded context) it would be subject to review. PAAB can provide an opinion if the piece is exempt. If you’ll want to proceed to approval if the piece is not considered exempt, please indicate this in the submission letter.

    • M

      Part 3 of the PM in HCP directed pieces
      • mef

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      M

      @Jennifer-Carroll Yes, it will be positioned in the context of patient counselling, as there is no other information of proper use of device in the PM (other than part 3)

    • A

      Advisory on Exclusivity Claims for Indications
      extneral advisory indication • • admin

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      736
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      Jennifer Carroll

      Hello @natbourre

      No, but the indication size should be proportional to the claim size Yes, it is acceptable to use the generic name.
    • M

      Clinical vs. Non-clinical claims
      • mef

      4
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      4
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      157
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      Jennifer Carroll

      Hey @mhe

      The answer is nuanced and context driven. While dosing has clinical relevance for appropriate use of the product, the convenience of once daily dosing does not necessarily translate into a clinical outcome such as adherence, safety, and/or efficacy. As such, a claim of “convenient once-daily dosing” would not require a disclaimer of “Clinical significance unknown” but it would not be permissible to present it in a context that suggests unsubstantiated significance.

    • A

      Guidance on Risk Management Tools (September 2016)
      • admin

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      567
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      D

      @admin We note that modifications to RMTs require PAAB resubmission. Would this still be the case for a product logo or legalese update that does not alter any of the other content in the RMT? If PAAB resubmission is required, is there a way for a reduced fee to be applied (we note that updated legalese or logos are not part of the criteria for "Minor Update" reviews).

    • A

      Advisory on the Use of Open Text Fields in APS
      • admin

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      2206
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      Jennifer Carroll

      Hey @laraholmes

      It’s unclear what “in this respect” is referring to. “Open text fields” are “blank” by definition as the rep determines the copy. The restrictions for open-text fields are that the manufacturer has confirmed the reps are trained to limit open-text to transactional element with no therapeutic, product or service/tool being mentioned (see full advisory above). It may be beneficial to set up a clarification call so that we can better understand your question. Please reach out to admin to set up a call with me.

    • K

      Pre-planned extension studies
      • KEOCA

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      Jennifer Carroll

      Afternoon @keoca

      No that would not qualify. Specific timepoints must be clearly indicated as pre-planned.

    • A

      Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising
      • admin

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      Jennifer Carroll

      @keoca Correct.

    • K

      This topic is deleted!
      • KEOCA

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      No one has replied

    • A

      Advisory on Small Space Ads
      small space ads banner ad advisory • • admin

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      No one has replied

    • A

      Advisory on Fair Balance Headings
      • admin

      1
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      553
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      No one has replied

    • A

      Tips for Document Names and Descriptions for External Use
      • admin

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      1344
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      No one has replied

    • A

      Advisory on APS Breakpoints and QR Code Links
      • admin

      1
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      1485
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      No one has replied

    • A

      Tips for Pre-NOC Corporate/Editorial Communications
      • admin

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      No one has replied

    • A

      Advisory regarding use of RAMQ in APS (April 2016)
      • admin

      3
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      3
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      1331
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      Jennifer Carroll

      Hello @jen_antibody

      Great question. To clarify, the request from RAMQ is to ensure that the coverage criteria are always clear and complete, so as not to suggest the indication is the coverage criteria (except where this is indeed the case). The document states: Coverage claims must be accompanied by reimbursement criteria (if applicable to the indications promoted in the piece). This means, that not all criteria are required in the piece. The discrete criteria which are not for the indicated population (i.e. off-label criteria), CAN be removed from the coverage criteria. All formulary claims, across Canada, for discrete off-label use would need to be removed, this is not exclusive to RAMQ. If there are additional indications for the product, which RAMQ does not cover, the formulary presentation/claim should be clearly limited to the indications with RAMQ coverage.

      A statement similar to “For information on availability of formulary coverage in Quebec, please visit link” would still allude to RAMQ and be subject to the RAMQ request. However, to reiterate, the RAMQ request does not preclude the removal of off-label discrete coverage.

    • A

      Guiding Principles for Digital Conferences
      • admin

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      No one has replied

    • A

      Guidance Documents for Claims Based on Kaplan-Meier Analysis
      • admin

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      4022
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      No one has replied

    • A

      Advisory on Advertising Messages Referring to “No Sub”
      • admin

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      516
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      No one has replied

    • A

      Advisory on Disclosure of APS Placement
      • admin

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      253
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      No one has replied

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