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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
616

We're developing a branded slide deck for HCPs that will include mention of adverse events as stated in the Product Monograph. It is our intent to provide HCPs with information on how to manage adverse events (e.g. educate patients on dietary measures, consider consulting a dietitian to modify patient diet if required, etc.). Is it correct to assume that the information on how to manage adverse events within this branded APS must be supported by a textbook or recognized third-party website/materials?

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615

Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!

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614

Is it acceptable to advertise a statement that says something along the lines of: "Drug X is the only drug containing active ingredient Y that is approved from clinical tests?" assuming that this statement is true? Would that change if the statement is more specific, such as "Drug X is the only epidural drug containing active ingredient Y that is approved from clinical tests?"

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613

Removed 07/2018


612

In the context of a Consumer Brochure, is it permissible to provide DINs for a balanced list of medication options?

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611

Section 3.1.10 of the Code states that "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." How do you know when presentation of the primary endpoint is warranted? Is it always necessary to present the primary endpoint when presenting data (i.e., a secondary endpoint) that is in the product monograph?

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610

The Guidance document 'Claims Based on Non-Inferiority Trials' states that "In the event the non-inferiority study failed to demonstrate superiority in the primary endpoint, one should not use secondary endpoints to suggest superiority." Does this still apply if the primary/secondary endpoints are unrelated (eg. primary endpoint is an efficacy measure, secondary endpoints are safety measures)?

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609

Hello. Can a pharmaceutical company post a tweet on its Twitter platform about its product winning a research/innovation prize? For example, "Congratulations to Product X for winning the 2017 YZ Prize!"

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608

If we pay for a beauty expert to talk about one of our OTC products live on a tv show like Breakfast Television (on City TV), should the beauty expert mention live on the show that they are being paid by a pharmaceutical company?

607

Does a HCP-directed website for a Schedule D vaccine need to be gated?

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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Code of Advertising Acceptance
click here
Pharmaceutical Advertising
Advisory Board
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Have a great summer and see you in September.