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Jennifer Carroll

Section 1.1.4 Endpoints/ Outcomes of the Guidance on Real-World Evidence states “Endpoints/Outcomes must be “consistent with” (though not necessarily “the same as”) those in the TMA. Regardless of whether the evidentiary basis for the presentation is RWE/RWD or an RCT, endpoints are not generally limited to those explicitly included within the TMA. Though the approach for RWE/RWD mirrors that for RCTs in this respect, the following examples are intended to clarify questions received during the consultation process.” You can review the examples in the linked document. Assessment of “consistent with” is made in the context of the combination of the endpoint, TMA and the therapeutic area. The submitter should provide authoritative support within the submission, to support that the endpoint is consistent or similar to those in the TMA and that it is a recognized endpoint within the therapeutic area.

Jennifer Carroll

Hey @mef

Thank you for flagging this. We've discussed the matter with the review team to ensure alignment and are updating both internal and external guidance documents for clarity. In most cases, study design footnotes may appear outside the box.

Jennifer Carroll

Good Morning @dmauri

This is a specific review question. Please submit the guidelines and proposed product claims. This can be done in a full submission or an opinion if you’d like further clarification prior to building out tools.

Jennifer Carroll

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.

Jennifer Carroll

Hello @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.

Jennifer Carroll

Hey @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.

Jennifer Carroll

Hello @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

Jennifer Carroll

Hey @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.

Jennifer Carroll

Good 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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