Hello @Jennifer-Carroll, would this mean that safety data from a comparative clinical trial would be permitted in a promotional piece (knowing that there is typically no p-value for safety endpoint), or would comparative trials still be subjected to the "Guidance on secondary endpoints" as other trials outside the PM? And, would it change if the study was NOT the basis for the approval, but was carried out subsequently? Thank you!
Remote Workshop 2020 series
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Comparative Biosimilar Data -
Abstracts and HCP websitesThanks @Jennifer-Carroll
Are there any scenarios where directing HCPs to conference abstracts could be acceptable, in the absence of any product claims (s3.1.2ii)? i.e., in an Unbranded/Editorial APS, or through the use of the Attention Icon Guidance? -
Guidance on which HCP Materials Require PAAB ReviewHey @mimi77
Yes. It would be considered discussion of drug therapy or content relating to drug therapy.
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Unbranded HCP website linking to a PAAB exempt toolHello @mimi77
During the review, you’d want to make the reviewer aware of the intended link. They will advise if it can be linked based on the content in the PAAB-exempt piece and the unbranded disease-state piece undergoing review.
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Abstracts and HCP websitesHey @ALee
Let’s ensure we’re talking about the same thing when we say “abstract”. When we refer to “abstracts” in the response above, we’re speaking to acceptable abstracts (the published abstract from a published peer-reviewed study that meets the standards of the Code).
This is in contrast to ‘abstracts’ per Code section 3.1.2ii:
“Please note that abstracts presented at conferences and/or in journal supplements (such as study design and results analyses) that have not been subject to independent review are generally regarded as not having sufficient evidence to support claims and may not be used as reference in APS.”The review would require PAAB to see the full published peer-reviewed study and the abstract to ensure the study is acceptable and subsequently, the link to the abstract is acceptable.
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Abstracts and HCP websitesHi Jennifer - to confirm the above, PAAB would review an on-label Abstract disseminated with (or linked to) advertising, and if there were no major concerns this could be an acceptable activity? Given the Abstract itself may not contain the detailed methodology required to conduct a review, would the Sponsor be able to provide supporting documentation such as the protocol, DoF, etc.?
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Citing patient preference in a patient profileHello @adelaidebaker
As a general principle, the clinical decision to prescribe or switch should be made based on clinical considerations. Patient preference can be a part of a patient profile but should not be positioned as the reason to prescribe or switch. Patient preference can be presented as a consideration, without drawing conclusions about clinical actions.
With respect to the specific case presented in the question, the copy in the guidelines and the APS would have to be assessed at the time of submission. We’d caution that “broadly defined” may be problematic and that drawing inference around patient choice such as “difficulty remembering to take pills and therefore might prefer injections” would require statistically significant evidence from a published high quality source. -
PAAB Forum Quarterly Review and eFiles Tag and CEI Report - Q2 - 2025Good Afternoon @Manufacturer and @Agency
It's crazy to say but we're now just past halfway through 2025!
The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q2. See the Tag report here and the CEI report here.
The Forum Quarterly Review for Q2 has also been posted here.
If there's more you'd like to know in Q3, let us know in the comments below. Have a wonderful rest of the summer.
Thank you
PAAB -
Product is "in stock" claimHi @support
A strictly informational statement about stock such as “Product X 5mg dose now back in stock” could be considered exempt.
The inclusion of the indication statement renders it no longer exempt.
The inclusion of a product photo MAY render it no longer exempt. This piece should likely be submitted for an exempt opinion to assess if the product photo can be used while meeting exempt criteria. -
eFiles - Scheduled Down Time - July 29th, 5pm-12amGood morning, @Manufacturer @Agency
PAAB will be performing an upgrade to the eFiles system tonight, July 29th. We will be shutting the eFiles system down from 5pm-midnight to perform the upgrade. Please note that users will not have access to eFiles during this time.
We’re sorry for any inconvenience that this causes.
Thank you
PAAB
