FYI post-approval change | preclearance exemption | what requires review | PAAB scope


Hi, I wanted to confirm whether an unbranded disease awareness website that does not speak about treatment would need to be a gated site? The website would be targeted to HCPs and we would have campaign emails and digital banners linking to the website. Would this website also be considered PAAB exempt because it doesn’t […]


Hello, I’ve had a launch announcement PDF file approved for e-mail distribution by PAAB. If I want to send this exact same file via fax, do I need to get it approved again by PAAB? Thanks. If the unaltered PDF is being delivered via fax, this does not require re-review but should be submitted as […]


Is the following service exempt from PAAB review, as we think it does not meet the the criteria for a promotional activity. A pharma company would use a vendor to include a link to a peer-reviewed, on-label, full publication for their approved product, on a website other than the journal in which that publication was […]


Hello, I work at an agency and one of our clients is considering a website for patients enrolled in their PSP. This website would be DIN gated at which point the patient can create an account using their email address. The patient would then receive a confirm profile email with a link to create a […]


Our corporate logo has recently changed. We would like to swap out our old logo with new one on digital assets that are PAAB approved. Do we need to notify PAAB as an FYI? Does this invalidate the approval somehow? Thank you. It does not invalidate the pieces. The transition of the corporate logo can […]


For communications of « contextual use of a product name », that doesn’t require preclearance, does it have to fall under the 5 criteria identified in section 1.5D of the code or does it simply not have to have a therapeutic claim or a promotional claim. ie. Does the statement « Call XXXXX for samples of product Y » […]


Hi, would the following be exempt or require review? a sheet with brand logo, a shot of the pills and a callout « visit » no claims, and the website is paab approved and gated. thanks for the insight. If the intent is for the ad to be in the consumer space, it should be submitted […]


If a third party group (e.g. patient advocacy) develops a DTC piece with mention of a brand- would it be subject to HC regulations? The message is by no means sponsored by the manufacturer, and no involvement from the manufacturer. Would this meet the definition of advertising? Independently created and controlled content is not subject […]


Hi PAAB, If a pharma company who markets a vaccine sponsors a 3rd party to commission the the writing of an independently written educational article on adult vaccines, in which all treatments are discussed and this vendor distributes this article to consumers through their channels, is this considered promotional? Would the article require PAAB review? […]


If launching a Patient Support Program, can a sales rep proactively distribute an unapproved PAAB enrolment form? Does the enrolment form need PAAB approval when product, disease state and eligibility criteria as well as prescription. Need to be PAAB approved? The patient enrolment form should be submitted for review to ensure that it meets the […]


Are medical devices specifically excluded somewhere in the PAAB Code of Advertising Acceptance book? Yes. See the « Healthcare Products » definition in PAAB code section 11. This exemption applies to class I, II, III, IV medical devices.


For traditional online banner ads, how can one be expected to fit the verbatim indication on the first 'frame' also containing a claim? Traditional banners are only a few pixels in size, which seems to prohibit effective advertising for products with larger indications. You are referring to the PAAB code 2.10 which requires that the […]


We are developing an unbranded APS (Journal Ad). This APS would contain statistics and data pertaining to disease state. This APS would be disseminated directly to HCPs via print publications and perhaps some e-publications. The call-to-action on the APS would lead HCPs to register for an accredited e-CME on the disease state. Will PAAB require […]


Hello, in case of branded APS, are references older than 10 years not accepted? Thanks! It is possible for an old reference to be questioned, but this is not necessarily the case. PAAB has rejected references which are less than 10 years old and PAAB has accepted references which are more than 10 years old. […]


With reference to PAAB Code section 6.6 (vii), what is the difference between class and category? Would an unbranded patient piece that mentions « treatment » without any specifics be exempt from PAAB preclearance? For further context, the disease state that the piece focuses on can be managed in various ways, including watch and wait. « Class » refers […]


Dear PAAB. The PAAB codes states that superlatives or special status cannot be used unless substantiation can be provided. What is the substantiation you are looking for? Is the monograph a source that would suffice? PAAB code section 5.16 requires that claims of status be supported by authoritative sources. The terms of market authorization (e.g. […]


Can I pharmaceutical company support the development of an independent third-party publication covering the highlights of a conference in a therapeutic area where it does not yet have an approved product? The report and a summary slide presentation with the same content is developed by an independent faculty of medical experts, who have full control […]


Section 11 of the PAAB code states: Use of the word 'new' or statements implying « new » in advertising should be restricted to 1 year after initial marketing. Can you please clarify what is meant by « initial marketing »? Is this the NOC date or when « marketing » activity is initiated etc.? One year from first distribution of […]


Hello! Would it be possible to know if there is a one year time limit for us to have an HCP education piece approved by PAAB after the launch of a new indication? Thank you! Advertising pieces can be approved by PAAB at any time during their life cycle (provided the product is approved by […]


Can a pharmaceutical company publish the results of a clinical study that was supported by a scientific grant. Would this have to be identified as advertorial? Clinical trials which are published independently in medical journals do not fall under the PAAB code (even if the trial is supported by a grant). If the manufacturer purchases […]

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