Recently we've seen an APS that have been submitted where p-values were requested for safety data, otherwise it would not be admissible as data. The problem is, virtually no clinical trials power their adverse events to generate p-values. When did this become a requirement?
If I have an APS which is left behind, however only contains the name of the product with no other information (i.e., company name, price, quantity, indication etc.), do I need PAAB’s approval?
Does an advertisement for an OTC product that will run in a medical journal require PAAB approval? The ad does include product claims, with references.
One of the pivotal trials for an advertised brand has a reference comparator (RC) arm (i.e., the trial has statistical analysis for the advertised brand vs placebo and the RC vs placebo, but no statistical analysis for the advertised brand vs RC). The Product Monograph mentions the RC as part of the design, but no RC data is included in the PM. Can the data for the RC vs placebo be shown in an APS?
Does PAAB have any specific regulations around infographics? It outlines study results.
We are creating a website for HCPs using Responsive Web Design, in which one set of content (text, images etc.) will automatically be populated into different layout placements based on the size and configuration of the screen on an HCPs device (table, smartphone, laptop etc.).
We would like to submit only 2 breakpoints for review (desktop & smartphone), because the tablet version will either follow the desktop size/dimensions – or the mobile, depending on the orientation of the screen (vertical or landscape).
Would providing layouts, copy and wireframes for the 2 breakpoints satisfy PAAB submission requirements?
Will you also require screenshots of the tablet version?
Will the different breakpoints require separate submissions? Or will they be reviewed separately but as a series fee?
Hi Patrick, Can a company position its brand (from both a creative and messaging standpoint) on secondary outcomes in its PM? If not, then what code number does this contravene?
Can a reprint be distributed by the Sales force where the use is within the approved indication, yet the reprint discusses endpoints that are not discussed within the Approved Product Monograph?
What are the requirements for display signs at a conference? The display sign contains pictures of drug products and contains general information about the product. Would fair balance need to be applied to this display? Are we required to include the indications on the display? This sign would only be used at conferences along with brochures which contain the indications and fair balance information.
Is it within regulation for a pharmaceutical company to disseminate information through patient groups (as opposed to through a health care provider).
We have a slide deck that is being presented to HCPs by members of our medical team. This deck is PAAB approved. We have a few questions. Can we record the session and place it on our HCP gated portal for other HCP's to benefit from? Does the recording require PAAB approval? In the post-production of the video, can we add chapters to the video so if physicians wanted to watch the video in segments, they can? Thank you.
If the URL for a PAAB approved HCP portal (which contains gated product information – PAAB approved) is included on the back of a sales representative’s business card, does the business card now require PAAB approval?
Hello PAAB, The approval on one of our APS's is going to expire and we would like to continue using this APS. What is the process to renew the PAAB approval? Do we need to resubmit everything for review even if nothing in the APS has changed? Thanks
Is there a PAAB mandate anywhere that states that the pharmaceutical companies corporate logo has to appear on all PAAB reviewed and approved APS materials? We have a situation there are high-priority approved APS materials requiring printing; however the corporate branding is changing and won’t be fully established for some time.
Hi, I am looking for a ruling on the following scenario. If a sales rep is using a PAAB approved, Un-branded, Disease state promotional piece to engage an HCP in a non-product related discussion. If, during that discussion, the physician asks that representative a product specific question, i.e. « What is the clinical data for Product « X » in the disease state we are discussing?”. Is the rep allowed to answer the question and switch to a product based discussion that incorporates PAAB approved promotional pieces? What specifically can the rep do in a situation like this where the use of PAAB approved messaging and promotional pieces are strictly reactive?
In 7.1.2, regarding retaining a stakeholder to do speaking/chairing meetings, etc —- slides/presentation of this stakeholder is not subject to PAAB review? Please confirm.
Does PAAB review and approve both the copy & the layout before they issue a PAAB approval reference number? Or is it only the copy which is reviewed and approved? Thank you.
Would an objective slide deck prepared and approved by the medical department of the company for the sole use by MSLs in their 1:1 interactions with HCPs be considered PAAB exempt?
Are accredited programs exempt from PAAB review?
If our company has sponsored a newsletter for a healthcare professional group (which official represents their professional specialty) that discusses updates to their independent website (password protected for members and sponsored by us as well) and the sales force is going to distribute this newsletter proactively, does it fall under PAAB's scope for review due to frequency of distribution/availability and sponsorship combination.
The website touches on best practices for a disease area including treatment so the newsletter will touch on updates to any of this and do mention our product. The company does not have any ability to alter content if there is a comment from PAAB. We would appreciate clarification as we were still not clear after working through the decision tool on the PAAB website (which is awesome by the way). We are running into similar issues with a disease and treatment video for patients produced by the same group (sponsored by us) which the sales force would also like to distribute broadly healthcare professionals as a DVD and show on their i-pad. (Again, no ability to change content). The two scenarios (newsletter and video) have similar components. Thank you so much for your guidance on this.