Hey @mimi77

This sounds like a file specific question which should be addressed with the review through the eFiles ticket system. If the question is with respect to “attestation letters” in general term, there are many different reasons an attestation letter might be required in a file. The person signing the attestation letter can vary depending on the copy. Most commonly attestation letters are signed by a representative of the manufacturer’s medical or regulatory team. It may be possible for it to be a representative from the global team. There are a number of Q&As which address attestations which may also support your understanding.

Hello @tk2022

It appears that you are asking for an exempt review over the forum. Please note that this is not the intention of the forum. From a search it appears that you are taking the term “simple sample” from Question 47 or 58. If this is the case, please ask the question under the relevant Q&A in the future to help maintain the usability and clarity of the Forum. Q&A Solicit product samples should provide sufficient information along with the referenced questions within that response, to assess “simple”. When unsure, please be invited to submit for an opinion.

Hi @caitlinbyrne

When an APS has more than one audience, all regulations for each audience apply. The tool would be reviewed to ensure it meets patient and HCP regulations. Generally the patient regulations are more stringent so we recommend strongly considering them when creating the tool.

Hi @hollymed

Please see this PAAB Forum Q&A

Hi @chagali-toney-0

Per the Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc “3. For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted.” Please note that this does not state “verbatim”. However, it should be interpreted to mean that no data from outside of the PM can be presented.

@jennifer-carroll Great, thank you!

Hello @mimi77

Promotion of a patient support program through the presentation of the program name and logo does not fall under the exemption criteria and links the brand logo to promotion of a company service (PSP logo) (Code section 7.5). Additionally, program names often have implications for the brand such as alluding to therapeutic use. Exemption is limited to brand name and logo in a context not linked to therapeutic or promotional messages per Code section 1.5.

Hello @lora_nolan

This is a review question. Per the Community Guidelines (see top right corner), this does not meet the use conditions for the Forum. Please address review questions through the appropriate channels by submitting a ticket for a call with the Reviewer through eFiles.

Hello @gmc

Hard to say whether this is even acceptable without looking at the study, but as a general question, we can state that this would require highest level fair balance. It is an implied claim of efficacy which would likely require quantification from the study (i.e., presentation of data). If it was stopped due to safety concerns, that would also prompt inclusion of that information and render it subject to highest level fair balance. With respect to “what other data is required for it’s inclusion?”, this is a review specific question. Please submit for an opinion as there are a number of factors that would need to be considered.

Good Morning @ebailey

All files do not need to come back together. You can update the parent file and then apply across all the children files. In general, the parent file should be the one being resubmitted; however we understand that there may be practical reasons to resubmit a child file to get it to approval prior to proceeding with the rest of the children and the parent. When this is the case, please outline this for the reviewer. You may also reach out with an email to admin to confirm that the reviewers agree prior to resubmission.

Hey @supriya

We’re unclear about the request. We can provide an example of how to cross-reference:

Insert an asterisk ( * ) at the point in the text where you want to reference the footnote.

At the bottom of the page, add the corresponding footnote, also marked with an asterisk ( * ).

Cross-references must appear on the same spread as the claim.
Multiple claims can be linked to the same footnote if the footnote would be the same for each claim.

If this is not the question, can you please provide additional context.

@jennifer-carroll said in Imagery:

which exceeds name, price, and quantity, this copy should be blurred to prevent advertising to the general public.

Thank you!

@jennifer-carroll Amazing, thank you so much!

Morning @constance

If the product has not received NOC, a manufacturer cannot promote that a new indication is coming soon as this would be off-label promotion.

@jennifer-carroll Thank you very much for the very comprehensive and helpful response!

@jennifer-carroll Thank you!

Hello @username

Apologies for not seeing this sooner.

Thanks for your question. To clarify, iterative submissions (i.e. different iterations within the same PAAB eFile) do not require light blue shading. Blue shading is requested for child files that are part of a series. The blue shading is used to identify the common copy between the child and the parent eFile.

However, whether you’re renewing an iterative submission or a series parent or child submission, you would shade the copy yellow. Once the submission is a renewal, it is more helpful to reference the backfile to which the copy is 100% pickup rather than shading it in relation to a parent file where the copy may be as little as 60% common.

When using the “express renewal” feature, we will not require that the shading be adjusted by virtue of the way in which the “express renewal” platform functions and the nature of the guarantee that nothing has changed.

Good morning @caitlinbyrne

While “now available” as a stand-alone message is exempt, when it is paired with another marketing claim (route of administration), the piece is no longer exempt. This piece appears to require lowest level fair balance if restricted to the copy noted above.