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


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?


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?


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.


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.


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?


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.

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