Patient Info
40
Topics
53
Posts
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.
-
-
-
457 - We have been asked to update a patient information booklet for people who have been prescribed the drug. The drug has two indications. Patients may have both conditions, but it's most likely that they have been prescribed the drug for only one of the conditions. Both indications are for adults only and both indications are described in the same Part 3 and use the same patient information booklet. Our drug is coming out with an adolescent indication for only one of the indications. We want to update the patient information booklet to include the adolescent indication. I think it should be fine to add the adolescent indication to the existing approved booklet as long as the adolescent info is in the same Part 3 from which the patient information booklet was developed. Are there any other considerations for putting the adolescent info in a separate booklet? There is not much new content to Part 3 except the age change. Thanks!
-
452 - We are creating an unbranded teaching easel for physicians to use with patients. The easel is highly visual but does show some disease statistics and mentions classes of drugs/protocols, but not specific brands. Because this piece is never given to the patient, does it come under the same content rules as tools the patient would take home? We want to minimize clutter and just let the physician speak to the images and answer patient questions. For example: - For disease stats, does all of the information on how the stats were collected have to be on the piece? If so, can it just be put on the back of the page that the physician sees, but the patient does not? - In the section where drug classes/protocols are named, does safety information have to be included? If so, again, can this be placed on the physician-view side only? Thank you.
-
-
-
-
-
-
394 - If a pharma company is developing a brochure that includes general information about clinical research to better educate patients who might be considering participation in a clinical trial, is PAAB (or another regulatory body) required to review and approve the brochure? Please note that this resource would not be developed for use during a specific trial; it is strictly for general patient education purposes.
-
-
335 - I'm creating a document for a drug that pharmacists will hand to the patient along with their filled prescription for this drug at the drug store. This document will include, "what you should know about the drug", "different medical conditions the drug treats" as well as "how the drug works." Will I need to add "Important Safety Information" to this document and if so what aspects will I need to include in this?
-
-
-
251 - The Code (in part) states: 1. that patient information is exempt from PAAB review if the information is direct from and consistent with the product monograph. 2. patient materials must be non-promotional. The questions, • if by PAAB's interpretation, would the content of PART III of a product monograph be exempt if produced in a multipage brochure layout, accompanied by product branding elements (colors, graphic design, brand logo, etc). • if a brochure layout is acceptable, then may the formatting be comparable, or are there restrictions or requirements related to formatting treatments for section titles, italics, bolded fonts, underlined text, etc.
-
-
-
-
83 - Once PAAB approves a patient information brochure, does it ever expire? In other words, can we reprint a brochure that was previously PAAB approved and distributed several years ago? Also, what if the product has a change in ownership - if the brochure was previously approved by the seller of the product, can the buyer of the product use the same content without re-submitting for a new approval? The only change would be the addition of the new owners trademarks and the removal of the previous owners trademarks.
-
