DTCA/I | consumer secondary audience

599

Suppose a Product Monograph contains pooled data presentations (demographics, efficacy, safety, etc), but the individual data sets are from separately conducted and published studies, with no planned pooling. Would it be acceptable to report the individual data in APS, or would PAAB require it to remain pooled (and subject to the associated limitations). Traditionally pooled […]

600

Regarding Code s3.1.1, does PAAB distinguish between different types of « pooled data »? For example a post-hoc pooled analyses of unrelated trials (low evidence), vs. a pre-specified pooled analyses of replicate trials (higher evidence)? Such pre-specified pooled analyses are commonly used in registration trials for certain therapeutic categories, and therefore interpretation of s3.1.1 could potentially be […]

601

I have a question regarding MOA and Code Section 3.1. Suppose a TMA states that Product-X targets receptors A & B, with no additional information/limitations. It is known that Product-X also targets receptors D & E, although this information does not explicitly appear in the TMA (as it is not intended to be a repository […]

591

HI PAAB, when a drug goes from pre-NOC to NOC, is it possible to use the wording « Now Approved In Canada ». Also, if this is marketed to general population, does it need PAAB approval? Thanks In response to your question regarding PAAB preclearance, consumer advertising does not require PAAB review. However, PAAB does provide an […]

588

I would like to clarify the requirements for a PAAB material review in relation to a US-only promotional symposium at an international congress held in Canada. Our US colleagues would like to host a learning theatre program on a product that is approved for use in both the US and Canada. If the program is […]

584

Can you please explain why a claim of « Guidelines recommend… » can only contain the generic drug name, vs. brand name? Would it make a difference if the Guidelines themselves link generic and brand names? Because guideline recommendations tend to specify the non-proprietary name. Some have expressed a desire not to be perceived as endorsing a […]

589

Hi there, I am currently creating a slide deck that the reps will use with their customers, and I am wondering how PAAB would like market research to be referenced? Is the project name, source, and date sufficient, or is there more information that PAAB requires? Thanks! As per PAAB code section 4.4.4, the reference […]

590

Hello, We plan to create a survey to gather statistics on lifestyle habits and general knowledge of the respondents on a virus in order to use the said metrics in a promotional tool, in the vaccination field. 1000 respondents is the usual number needed to produce relevant or serious statistics. The question is: As per […]

582

Can NBRx data be used to make market share claims, if the same principles governing TRx data were applied? Example: Arbace is the #1 dispensed hypertensive among new patients. If so, would the NBRx data need to be directionally consistent with the TRx data (ie. if Arbace is in fact not the #1 dispensed among […]

585

Hello – I understand that data exceeding the duration of the TMA is not acceptable (eg. TMA study A is 1 year in duration, new study B is 2 years in duration). However in a situation where a registration trial is designed to read out to 3 years, and the TMA only contains year 2 […]

586

If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read « brought to you by a leading pharmaceutical company » or does it have to specifically mention the name of the company that […]

572

As part of our initial approval for a drug, we currently have an indication for the treatment of condition X. An additional trial has been published for cancer patients with condition X. The dosing remains consistent with the initial TMA. Can we promote our drug for cancer patients with condition X? This case would best […]

573

Hi, Is it allowed to develop a tool for physicians that will be used with a patient to help the patient make the decision to use a specific therapy? if yes, should the information in this tool restricted to Part III of the PM only or other sources are also allowed? Thank you! I assume […]

574

I intend to submit a non-branded APS into PAAB shortly. One call to action we are considering is a link to a URL that has been ASC approved (but not PAAB approved). We intend to link to not the whole site, but rather a particular section of the site. Would this subject the entire website […]

575

Our question is related to Question #70 which was: « The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 […]

576

We are in the process of developing a tool that will highlight a product's reimbursement program. It would state « reimbursement navigation assistance available for Product X » and would include a tear pad with necessary information to be completed by an HCP. This tear sheet would not be provided to patients, but would be faxed directly […]

577

Hi – I understand that as per Section 6.6iv, an email informing HCPs about 'updated provincial formulary criteria for Drug X' would be considered PAAB exempt (if there were no linkage to therapeutic or promotional claims). Could you provide clarification on whether including a website link to the full formulary list of a province would […]

578

Hi PAAB: We have a new product in our pipeline that is currently undergoing approval process with Health Canada (pre-NOC). We want to do a targeted campaign to HCPs around disease state, We will not be mentioning any clinical data or clinical options. This online piece will be centered around the disease and very general […]

579

When a disease is very rare, there is often no published Canadian specific epidemiology or incidence studies. What is PAAB's position on allowing a simple statement that the disease is 'rare'? Given the nature of the statement, we can consider review papers as support.

580

Hi, My question pertains to the construction of the required « Relevant warnings and precautions » section include in a fair balance section. Specifically, can the incidence of the events, for example « serious adverse events of neoplasm' or « QTc prolongation », have incidence or other clarifying information included in the fair balance section for clarification purposes so a […]

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