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  Clarification on indication inclusion in multi-Product APS
  J Jennifer Carroll

  Hey @Supriya

  This appears to be a specific question about a specific piece. The piece should be submitted for assessment. The forum is for general questions. As an example, a general question here might be “Is the inclusion of an indication statement required in materials directed exclusively to healthcare professionals, where no therapeutic or pharmacologic claims are presented”. The answer to this question would be, that the indication is not required when there are no marketing benefit or therapeutic claims (see Marketing benefit claims: What are they and what level of support do they require?).

  General Discussion

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  Price Comparisons
  J Jennifer Carroll

  Good Morning @Constance
  PAAB would need additional information to make the assessment of the claim proposed above. There are many considerations outside of just the source such as, does it suggest equivalence between products on a per unit basis and what is the intent of the per unit comparison. Given these unknowns, it is difficult to provide a definitive answer in a general space. We suggest submitting the copy for review.

  Claims & Support/References for Claims

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  Price Comparisons
  C Constance

  hi Paab!

  I would like to develop an APS to highlight all of the Rx products we have in our portfolio (all with the same indication). Provided I can find a compared prices must come from a single independent source (as described in question 438), would I be able to present the price as a unit cost? For example, the price of injectable pen X is $450 for 450 units, i.e. $1/unit.

  Claims & Support/References for Claims

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  Prescription Pads/Tools
  J Jennifer Carroll

  Hey @GMC
  This copy would be reviewed in the context of the entirety of the piece. The context of the message “dispensed as written” will matter. See also the PAAB advisory on Advertising messages referring to "no sub".

  PAAB Code

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  Prescription Pads/Tools
  G GMC

  Jennifer, what about an image of an Rx pad in APS with "dispensed as written" copy on the image?

  PAAB Code

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  Assessment of Risk Management Tools (HCP/Patient)
  J Jennifer Carroll

  Hey @mhouzer

  The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

  Comments & Feedback

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  Assessment of Risk Management Tools (HCP/Patient)
  M mhouzer

  Can you please clarify what the difference is between the Standard (4-day) and ARO-4 in the attached?

  Thanks

  Comments & Feedback