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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
619

We’re working on a new product launch and our client is looking to do a PAAB-exempt pull up banner (just product logo and legal text), however, this product has received an NOC/c approval. Are we required to put the NOC/c box on the banner, which disclaimer sea the indication statement?

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618

Hi there, We have some emails with only company information, no talks about therapeutic area, nothing about brand. We plan to send it through PTM targeting HCPs. Does this need PAAB approval? Thanks

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617

Is there any particular PAAB guidance around acceptability of a program names for patient support programs? Is the name something that requires PAAB review? Any further details you can provide would be appreciated.

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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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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

To view the PAAB
Code of Advertising Acceptance
click here
Pharmaceutical Advertising
Advisory Board
Upcoming meeting

September 25, 2018

A reflection on digital pharma practices

Dinner Meeting
Cocktails: 5:30 p.m.
Dinner: 6:30 p.m.
Panel Discussion: 7:00 p.m.

Click here to register