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    • K

      Formulary message - exemption confirmation
      PAAB Q&A • • karen.taylor

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      No one has replied

    • D

      Patient Satisfaction Claims
      Claims & Support/References for Claims • • Danielle

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      Jennifer Carroll

      Hey @hannah

      Please see Q&A 338 listed above.

    • A

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

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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.

    • Jennifer Carroll

      Register for PAABs ARO Q&A Session - May 18th
      Announcements • • Jennifer Carroll

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      Jennifer Carroll

      @Manufacturer @Agency

      There's still time to sign up and join over 150 people registered for the interactive Q&A session on the Accelerated Review Options (ARO) pathway and the new submission guidance documents.

      Registration link can be found in the post above. Hope to see you there.

    • K

      Pre-planned extension studies
      Guidance on Code Application • • KEOCA

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      Jennifer Carroll

      Afternoon @keoca

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

    • B

      Inclusion of trial patient characteristics within a Rep CVA
      PAAB Q&A • • brendaarmit1

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      B

      @jennifer-carroll Thank you!

    • G

      Patient Support Program Enrolment Form
      PAAB Code • • GMC

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      Jennifer Carroll

      Good afternoon @gmc

      The form is not exempt as service oriented messages to patients/HCPs are still subject to review. See FB on PSP enrolment forms for related information.

    • A

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

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      Jennifer Carroll

      @keoca Correct.

    • K

      Deep link to patient website in an HCP email?
      Miscellaneous • • KEOCA

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      Jennifer Carroll

      Hi @keoca

      Yes. Messaging should be clear that you are directing them to the website to see content intended for patients.

    • G

      Fail Balance
      PAAB Code • • GMC

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      Jennifer Carroll

      Hello @gmc

      No. This would not meet the specifications outlined in Guidance on Generating the Three Levels of Fair Balance

    • K

      Unbranded patient counselling materials
      PAAB Q&A • • karen.taylor

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      Jennifer Carroll

      Hello @karen-taylor

      Code section 1.4.D states “The Code applies to all Advertising/Promotion Systems and corporate messages directed to licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and related health disciplines, to institutions, and to patient information that will be distributed by or recommended by a healthcare professional.”.

      From the provided description, it appears that these pieces would be considered patient materials that are subject to the PAAB code.

    • N

      SEM Keywords
      Electronic Media • • NKH

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      Jennifer Carroll

      Hello @nkh
      It would not be acceptable to purchase other sponsors brand/generic name even if it was a product for use before or along with the sponsors product as this would create a link to the therapeutic use of the sponsors product for patients who are on the other brand but not the sponsors. This would be considered direct to consumer advertising which goes beyond name, price and quantity and which advertises the therapeutic use of the product.

    • G

      Formulary comparisons
      Claims & Support/References for Claims • • GMC

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      Jennifer Carroll

      Good morning @gmc

      PAAB has issued advisories and guidance regarding formulary claims since 2010. In addition, we have received feedback from formularies regarding the presentation of formulary coverage in APS since then. The 2010 eFile may not reflect the more recent information and should not be used as precedent. We suggest submitting for an opinion should there be more specific questions regarding the proposed project.

    • B

      Pre-NOC submissions
      Non-product branded APS, pre-NOC teasers • • brendaarmit1

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      B

      @jennifer-carroll Thank you Jennifer. That does help.

    • J

      Informational Communication to HCPs on DTCI Campaign
      DTCA/I, consumer secondary audience • • jd

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      Jennifer Carroll

      Hello @jd

      Yes, it is acceptable to inform HCPs of a DTCI campaign. The communication would be subject to the PAAB code and should be clear that it is consumer information or advertising. The inclusion of the manufacturers name would be required. The communication of the DTCI campaign does not automatically render the DTCI campaign subject to review by PAAB, though the content should be submitted with the review of the HCP communications so that PAAB may ensure that the totality of the message is acceptable. As one example, it would not be acceptable to tie a brand to the DTCI campaign for the HCP if the content within the DTCI campaign went beyond what would be allowable for the brand.

    • Jennifer Carroll

      Submission Process and Features - Introductory Video Series
      Newsletters/Blogs • aros submission • • Jennifer Carroll

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    • A

      Fee Calculator now LIVE
      Announcements • • admin

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    • G

      Unbranded Patient APS
      PAAB Code • • GMC

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      Jennifer Carroll

      Hey @tmcm

      Yes, a compliant unbranded disease information pieces/tool could be created to be provided to patients by healthcare professionals. Patient information should be supported by consensus groups and authoritative sources. Guidelines are considered an acceptable source for disease targets in an unbranded patient piece.

    • D

      Patient Lifestyle Apps
      PAAB Q&A • lifestyle apps patient lifestyle apps psp support resources • • Danielle

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      Jennifer Carroll

      Hello @danielle

      Independent third party lifestyle apps may be promoted within branded apps if they do not contradict copy within the brands TMA. PAAB would ask to see the app content to ensure the link is acceptable.

      The review of linked 3rd party apps focused on lifestyle and nutrition vs lifestyle, nutrition and disease information is not different however there is increased opportunity for content which is not acceptable to arise when disease information is discussed.

      Additional clarification would be required on the last question that would be better suited for an opinion submission so that all aspects of the activity can be assessed. For example, is the 3rd party app only accessible through the PSP (not open to the public)? When this is the case, clarity over influence, sponsorship and distribution may impact if the content requires PAAB review.

    • L

      Renewal: Layout Only
      Guidance on Submission Procedures • • llow5

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      Jennifer Carroll

      Hello @llow5

      You are correct for straight renewals if the previous file contained a copy correct layout. For minor updates, a revised English layout and French layout or French copydeck would be considered acceptable.