Hey @Username
“Schedule 2” is a bit broad. There are many factors and combinations to consider. Could you provide the product or therapeutic class, or Federal drug schedule (see link) to help narrow down the response. Alternatively, if you’re not comfortable sharing in a public space, you can email review@paab.
Manufacturer
Private
Posts
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Comparative therapeutic claims of schedule 2 products in DTC setting -
RWE Data presentationHello,
Can you please clarify for RWE study presentations, if the footnotes (e.g. for study design, etc.) need to appear within the grey box and hence, before the fair balance - or after the fair balance (which would place it outside the grey box?) We have received two slightly different directions from PAAB on the placement of RWE study footnotes. Thanks. -
Pre-NOC storyboard reviewHello @Jennifer-Thomson
It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval. -
RAMQ criteria vs. notesHey @ALee
The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included. -
Update - Changes to the eFiles submission form requirementsHello @manufacturer @agency
Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact.
What's changing?
PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact.Click here to more about why, new form requirements, and what this means for the review process.
Question? Post below and we'll get back to you.
Thanks
PAAB -
Abstracts and HCP websitesHey @ALee
Not at this time based on PAAB code section 3.1.2 but something we can keep on a list to explore in the future. -
Comparative Biosimilar DataGood morning, @Username
Comparative data remains subject to the guidance for evidentiary basis to support comparative claims. As noted above, consideration may apply when the study can be demonstrated to be the basis for approval of the biosimilar. A study that is NOT part of the basis for approval and completed post approval, should meet the standards for high quality evidence (i.e. pre-defined statistically significance endpoints).
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Promoting a specific clinic in a branded APSGood morning, @copycallosum
In theory, this sounds like an acceptable activity.
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Formulary messaging clarificationHey @adelaidebaker
- Yes.
- Experience claims should not be positioned in a manner which suggests significance to the listing or vise versa. It cannot be stated or inferred that the experience is linked to coverage or that coverage is due to the experience.
- Patient information should be informational and not promotional. The copy “Now covered on ODB” would be considered promotional. For acceptable communications around formulary coverage, see Guidance on branded patient information section 1.3 Formulary Statements.
