Press Releases, Financial Reports, Unsolicited Requests
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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697 - I have read the HC Policy 'Distinction between advertising...' for Press Release (PR). However I see many PR online that go beyond simply stating name and therapeutic area. Many PR mention efficacy and safety data. Am I misinterpreting the HC policy or can we in fact speak to the degree of efficacy and safety in a PR?
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222 - What are the restrictions regarding reporting on efficacy in a clinical trial in our news releases? We will be issuing a news release when we receive NOC. We want to say what improvement in patient health was observed in the trial. The trial compared our drug to placebo. How can we explain what happened?
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82 - We are currently preparing our submission for a new product to Health Canada. In the meantime, the company is preparing it's financial report for the investors and they would like to include a section on the disease, it's implication on patients and a section on the molecule itself with results of it's phase III trials. Are there any restrictions, and/or do we have to submit the report to PAAB?
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68 - What is the Canadian specific definition for "off label" regarding reprints? FDA in it's draft guidance Good Reprint Pratices refer to indications and treatment regimens. PAAB code section 3.2 indicates material "must be consistent" with the indications, dosage regimens, efficacy and safety information information in the Cdn TMA. If the article is not specifically listed in the TMA, does it automatically be become "off label"?
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