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Miscellaneous

124 Topics 194 Posts
PAAB Notice
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.

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  • Jennifer CarrollJ

    391 - Are notes to HCPs allowed to be attached to PAAB material or approved studies. If not, where is this referenced in the code.

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  • Jennifer CarrollJ

    388 - I am a journalist doing a story on what advertising and or perqs are allowed to be given to doctors and medical professionals to use/prescribe a drug. What regulations are in place governing what is aimed at the medical professional?

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  • Jennifer CarrollJ

    386 - I am developing a gated HCP website that requires the HCP to enter his/her license number to gain access to the site. Do you have any recommendation as the where to purchase a list of valid license numbers? Thank you.

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  • Jennifer CarrollJ

    379 - I just want to know the complaints process for PAAB files.

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  • Jennifer CarrollJ

    370 - We have a question related to the placement of formulary messaging on sample boxes. Is it acceptable to place a formulary sticker on a sample box? If so what kind of approvals would be required to permit this action?

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  • Jennifer CarrollJ

    367 - Where in the code does it stipulate the requirements for communication between Health Care Professional to Health Care Professional?

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  • Jennifer CarrollJ

    366 - If the product is in a therapeutic area where we cannot use IMS data because of market definitions, can we use patient chart study or any other form of study to show our performance in the market. Are there specific guidelines on sample or methodology?

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  • Jennifer CarrollJ

    361 - Has there been any code infraction of late that you can share to us? And what does PAAB do about it?

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  • Jennifer CarrollJ

    354 - What is the process to follow if I disagree with a reviewer's ruling and want to challenge it further?

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  • Jennifer CarrollJ

    341 - If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review? Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.

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  • Jennifer CarrollJ

    340 - Can a fractional advertising insert (on light cardboard stock) be - inserted - loose with a medical journal that is polybagged - or glued on the f.p. size : 2 1/2"x 10" or 4" x 10" printed on both sides insert to be glued on the f.p.

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  • Jennifer CarrollJ

    333 - I was wondering where I could find information on pharma companies referring a patient to a specialist on their website or a third party website.

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  • Jennifer CarrollJ

    331 - What are the rules/regulations of non-pharmacological aspects on branded pieces. For example are questions about symptoms acceptable?

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  • Jennifer CarrollJ

    319 - I am confused on how Section 6.6vii is different from Consumer Brochures in "The distinction between advertising and other activities". The only differences I can think of is audience (patient vs. consumer), branding (branded vs. unbranded) and treatment discussion (no mention of treatment vs. objective discussion of all available treatments). Am I on the right track? Thanks!

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  • Jennifer CarrollJ

    318 - HI, will the new market created by HC under the MMPR require the Licensed Producers to work with the PAAB?

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  • Jennifer CarrollJ

    304 - If a PAAB opinion is requested for a specific, does a positive or negative opinion affect the outcome of a subsequent clearance review?

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  • Jennifer CarrollJ

    302 - If the audience is not hc professionals and not consumers- somewhere in the middle (private drug plan managers)- how should this audience be treated?

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  • Jennifer CarrollJ

    301 - Does clinical trial advertising material need to be pre-cleared? If so, by who?

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  • Jennifer CarrollJ

    287 - PI, when required or when necessary, must form an integral part of the advertising message, which may be accomplished via a reference to a website link in a printed piece or by a direct electronic link to a website. If I am reading this correctly, as long it is placed on the ad page where they can find full prescribing information, I do not have to include prescribing information with my publication. Thank you

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  • Jennifer CarrollJ

    274 - I run a medical information line for patients and Healthcare providers for a pharma company. Do I need to either read or have on the front end recording the safety statement from the PI prior to speaking with the customer?

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