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A

amyl

@amyl
Agency
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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Recent Best Controversial

  • Series submissions for brands under one PSP umbrella
    A amyl

    Hi there,

    If a group of brands are under one PSP umbrella and are developing enrolment forms that will be identical, except for the products mentioned, logos, indications, and dosage for the particular products, will we be able to submit these as a series submission? I have seen series submissions for pieces within one brand with multiple indications, but wanted to confirm if this is still possible for a similar piece for different brands as described above, as long as they are >60% identical.

    Thank you in advance for your guidance!

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

  • PAAB Renewals/Resubmissions
    A amyl

    @jennifer-carroll Thank you very much for your response. We will submit the formal request.

    PAAB Q&A

  • PAAB Renewals/Resubmissions
    A amyl

    Hello, I have a general question about renewal submissions and would greatly appreciate any insight you can provide.

    I have 10 pieces that are currently expired (and a few that are due for expiry this month) that need to go in for renewals. However, we are expecting a minor PM update in late October/November so all of these pieces will need to updated with the new PM and resubmitted again in December. We are wondering if it is possible to get an extension on these pieces for renewal in December, rather than submitting in October and then shortly after with the PM updates in December. This would be extremely helpful in creating efficiencies and will help streamline our submissions and reviews.

    Thank you again!

    PAAB Q&A
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