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C

charlton

@charlton
Agency
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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Recent Best Controversial

  • Promoting to hospital buying groups/administrators
    C charlton

    Are there any restrictions when it comes to promoting prescription medicines to hospital buying groups or hospital administrators? How are they categorized on the consumer vs patient vs HCP spectrum?

    Miscellaneous

  • Definition of a pragmatic trial
    C charlton

    Forgive my ignorance but as pragmatic trials are relatively new, it would be helpful to know how you define "pragmatic trial" and where they fit in the taxonomy of clinical research (e.g. experimental vs observational; and if observational, analytical vs descriptive).
    Thanks.

    Real World Evidence (RWE) guidance document

  • Conference booth regulations
    C charlton

    Can a pharmaceutical company have a product branded booth at a conference where the disease state in question is off label? For example, could a company promoting an antihypertensive have a booth at an obesity conference?

    PAAB Q&A off-label conference booth

  • FYI for a price update?
    C charlton

    We have a recently approved APS that includes the price of the product. If the price changes, and we make just that one change to the piece, can this be handled with an FYI email?

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

  • Brand name only
    C charlton

    The recent PAAB Advisory on Small Space Ads is very welcome. However, it doesn't quite answer a question I have. If I have a static (one frame) banner ad, and I only want to direct the viewer to a landing page where we offer further information and samples, can I use the brand name only, without the indication and fair balance? There would be no claims.

    Electronic Media

  • Patient case studies
    C charlton

    Thanks for your reply. However, I'm still not clear about whether the patient is required to have been one of the patients included in the trial included in the PM.

    Claims & Support/References for Claims

  • Patient case studies
    C charlton

    Are real patient case studies, used to illustrate before and after effects, which were not taken from the efficacy studies in the PM, acceptable in a branded piece?

    Claims & Support/References for Claims
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