Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear all,
I am working on a NDA and we need to address why we are not considering a REMS is needed for our DP. Any comments/advice on how to go about it? I was looking for a template, but I have not been able to find one.
Best regards!

I do not know of a template, but you should file the rationale for not having a REMS in Module 1.16.1 Risk Management (Non-REMS). FDA issued a guidance on REMS a few years ago that you might find helpful in putting together the rationale.

https://www.fda.gov/media/100307/download

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 11-May-2020 17:16
From: Anonymous Member
Subject: REMS Assessment

This message was posted by a user wishing to remain anonymous

Dear all,
I am working on a NDA and we need to address why we are not considering a REMS is needed for our DP. Any comments/advice on how to go about it? I was looking for a template, but I have not been able to find one.
Best regards!

All depends on your safety profile. There is no answer for all.

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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
------------------------------

Original Message:
Sent: 11-May-2020 17:16
From: Anonymous Member
Subject: REMS Assessment

This message was posted by a user wishing to remain anonymous

Dear all,
I am working on a NDA and we need to address why we are not considering a REMS is needed for our DP. Any comments/advice on how to go about it? I was looking for a template, but I have not been able to find one.
Best regards!

This message was posted by a user wishing to remain anonymous

FDA released a guidance in early 2019 Immunogenicity Testing of Therapeutic Protein Products where there is a very nice lay up of demonstrating the thought process behind what assays were selected for the study, how sample collection was determined in the protocol, leading to observed safety, immunogenicity and its association with product quality and GMP batches used. The recommendation was to present an integrated summary of immunogenicity report and in the last section of the report clarify why or why not REMS is needed. I think this is an effective way to think through the approach. Product quality, safety, potential for abuse are some key factors to consider in addition to the REMS guidance.
Original Message:
Sent: 11-May-2020 17:16
From: Anonymous Member
Subject: REMS Assessment

This message was posted by a user wishing to remain anonymous

Dear all,
I am working on a NDA and we need to address why we are not considering a REMS is needed for our DP. Any comments/advice on how to go about it? I was looking for a template, but I have not been able to find one.
Best regards!

You may try this link to a DRAFT Guidance:
https://www.fda.gov/files/drugs/published/Format-and-Content-of-a-REMS-Document-Guidance-for-Industry.pdf


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Homi Dalal RAC
Consultant - Brandwood CKC
Sydney NSW
Australia
------------------------------

Original Message:
Sent: 19-May-2020 15:43
From: Anonymous Member
Subject: REMS Assessment

This message was posted by a user wishing to remain anonymous

FDA released a guidance in early 2019 Immunogenicity Testing of Therapeutic Protein Products where there is a very nice lay up of demonstrating the thought process behind what assays were selected for the study, how sample collection was determined in the protocol, leading to observed safety, immunogenicity and its association with product quality and GMP batches used. The recommendation was to present an integrated summary of immunogenicity report and in the last section of the report clarify why or why not REMS is needed. I think this is an effective way to think through the approach. Product quality, safety, potential for abuse are some key factors to consider in addition to the REMS guidance.
Original Message:
Sent: 11-May-2020 17:16
From: Anonymous Member
Subject: REMS Assessment

This message was posted by a user wishing to remain anonymous

Dear all,
I am working on a NDA and we need to address why we are not considering a REMS is needed for our DP. Any comments/advice on how to go about it? I was looking for a template, but I have not been able to find one.
Best regards!